May
22nd, 2009:
Dean:
I wanted you
to know, that your work, on behalf
of all damaged, destroyed by
LASIK---the lies, the subterfuge,
fraud, ----------your work has been
extraordinary in the face of all
that you, yourself have had taken
from you by this barbarous chapter
in medical history.
It resembles so much the era of Nazi
Germany--so many people who said,
"they didn't know"---
In this case, it is some of the
doctors who finally are coming to
the fore and saying "they didn't
know"----but they did.
Let every one of them who have
embraced LASIK, have it performed on
them----let them pay for what they
so dearly embraced----their enhanced
income, health of the patient be
damned.
Shameful. Disgraceful----,the
actions or rather inactions of the
FDA and entire Medical Community.
They have all the tears, and blood
of those ruined careers, lives on
their hands--and ultimately, on
their heads.
Survivors of the Holocaust, echo,
"Never forget"----
We should never let any of those who
participated in this atrocity
forget---a list should be
compiled----and shared.
They should pay. And they will.
The Bible says "an eye for an
eye'----how appropriate.
May
11th, 2009
Dean,
Thank you for taking the time to
speak with me today and helping me
through what is undoubtedly the most
difficult experience of my life.
Your advice on how to proceed,
despite the setbacks we have
suffered at the hands of those who
we entrusted to better our lives, is
invaluable and very much
appreciated.
I very much want to take legal
action against those whose greed has
resulted in immeasurable pain to us,
as well as many others close to
us. Dr. Emil Chynn and his practice,
Park Avenue Laser Vision, need to be
held accountable for the
debilitating effects their
dishonesty and malpractice have had
and will continue to have on my
life. As advised, I will contact
Todd to discuss this goal with him.
,
xxxx
May 4th, 2009
Thank you for your kind response.
How can I obtain my records? Should
I
just ask my surgeon? Basically, I am
struggling with intense
pain/pressure behind my eyes and
along my brow line. I also have
extreme
irritation, I have been on countless
steroids and other drops (Restasis,
pataday, antibiotic ointment). They
have said I have allergic
conjunctivitis and blepharitis but I
can't imagine that would be causing
such pain in my eyes. I have been
told that I have no refraction error
and I am seeing 20/15 but I have a
constant headaches and I feel like
my
eyes are straining to focus. My
doctor thinks that I should be happy
with my results but I am miserable!
I am a graduate student in the
process of writing my thesis, I also
do a lot of microscope work.
Needless to say, the lasik
complications are interfering with
every
aspect of my life. The doctor also
mentioned that I have a dry spot on
my cornea that he would like to
"scratch" to initiate healing.
Basically
give me an abrasion...I don't think
he really has any answers and is
using the kitchen sink approach.
I am sorry to be so long winded but
I can't seem to find any help.
Sincerely
xxxxxxx
May 1st, 2009
Atlanta Braves Catcher, Brian
McCann's vision ruined from
LASIK...He tried contacts and
glasses, but may need further LASIK
surgery.
http://www.ajc.com/sports/content/sports/stories/2009/05/01/brian_mccan_injury.html
April 30th,
2009
Dear Dr
xxxxxxx,
I'm an 18 years-old Asian who had
custom-wavefront LASIK on 3/4/2009
in Vietnam. After the surgery, I
experienced very noticeable
starburst and halo that seemed to be
unimproved after two months. I also
notice my contrast sensitivity on my
right eye is more than the left one.
My pupil is about 4-5 mm (measured
in light condition). I've asked my
doctor but he was very impatient and
didn't care about my problems He
said that my condition would be
improved in six months. I'm worry.
Do I need an enhancement or not?
Will the enhancement remove the
starburst, halo and contrast
sensitivity problems? Does the
enhancement cause dry eye?
I'm going to the US to study at
8/15/2009 in New Orleans. I was
confused by both the information
provided by LASIK company and LASIK
complications website. Where
can I find the right doctor in
Louisiana to resolve my problem?
Thank you very much.
April 13th,
2009
Hello,
My name is xxxxxxxxxxxxxx and I'm
terrified mother of 24 year old son
that just recently had a lasik surgery
done on both eyes. It was a
Customvue Wavefront Intralasik done
in Edmonton, Alberta Canada. Before
the surgery his right eye was +3.5,
the left eye which is a " lazy eye"
was +3.25. This is a 6th day after
the surgery and his right eye vision
is same as before surgery, left is
worse and both eyes are very blurry,
so he can not see much from close or
distance ( no computer, TV, driving,
working). He is using his drops as
prescribed, keeps his eyes closed as
much as he can, but there is not
even slight improvement. He is
devastated and afraid that it will
be another Lasik disaster. He called
his doctor's office with his
concerns, the assistant was
surprised, but she looked at his
record and told him that everything
looks good. I do not know if what he
is going trough is normal, but I do
not have a great trust in the doctor
either. He was not present during
the initial consultation, he did not
respond to my sons phone call, but
his assistant. I would like to ask
you on my sons behalf if it would be
possible to schedule a consultation
with you. He will fly to Florida at
any time suitable for you. Thank you
very much.
March 30th,
2009:
My vision was also ruined by Dr.
Nick Caro of Saint George Vision
Center, Chicago, IL. Thank You
Dean, That Monster Damaged my eyes
and my mothers eyes as well. I am
familiar with the site because of
mortgages business, but let me know
what is that exact part of the
website, That I can file the
complaint. I too Suffered I drove
from Detroit, Michigan, like I
explained... me and my mother were
tired of wearing glasses, 01-02-98.
I remember the assistant Leo was
performing the procedure Within the
next 20 days must eye began to hurt,
all I saw was a white cloud, for my
in my left eye. I was scared we got
in the car my stepfather we drove to
Chicago as fast as we could non
stop, it was Sunday. we called his
office it was an emergency, he
waited till Monday, when it got
worse negligence. I can remember
Nicholas Caro said " it will be okay
" of course I was scared senseless
out of my mind. I could not sleep
nightmares, also found the retina
was detaching in the right I seen a
retina specialist, he recommended
doctor in Arlington heights did
help, only thing good happened, 20
trips back in forth, he said go to
cornea specialist. Till this day I
have contained some type of
inflammation above the sinus area
above the left and side of my right
ever since that excuse my French "
freaking surgery " I was a young
man, I had corneal transplant after
in Michigan, living nightmare, you
can gladly share this story.
Whatever you need from my part, I am
glad to help put this soulless
monster from hurting anyone else,
seems like the law protects the
trash, I wondered if he was involved
with the mafia. since the protected
him like a bullet proof vest. I am
also sorry for you Dean, I did not
know so many people were against
him, I had almost forgot about him,
until 2 years ago I drove past that
place and I was so angry old
feelings. Bottom line " Justice
needs to be done, I don't care about
the money, but as long he loses his
license does not hurt anyone and
does not get rich off, someone's
dreams with his false promises, and
affects peoples lives and their
families, My Godfather - Uncle Jose
my mother brother said that is just
you guys till 2 yrs ago , a doctor
told him, that guy Caro is bad news
in Spanish, he has so many lawsuits
it is not funny...
Regards,
Gil
Chicago, IL
February 4th,
2009
Hi Dean,
I have to head out to work right now
but hopefully I'll be able to talk
to you sometime about the problems
that I've been having after
Lasik. Some support in dealing with
the decision I made to go through
with Lasik surgery and advice on how
to get better would be much
appreciated. I'm in Canada.
I'm 8 weeks out of lasik and I'm not
pleased at all with my decision thus
far. After reading through the
various different internet forums
and articles after the fact I now
realize that is was the most
reckless decision I've made in my
life. Especially since my correction
was only a mild one. Figure it will
be extremely hard to forgive myself.
Currently I'm in constant pain, it's
the most annoying when I try to read
or work on the computer but it never
stops even when I sleep (enough so
that it is seriously limiting the
amount of sleep I get each night).
From my latest visit with the clinic
and a second optometrist it seems
that my problems could be a
combination of allergies, dry eye,
and eye muscles and a brain trying
to get use to my new eyes. We will
see how it all progresses. I'm
having a hard time making it through
the day, not sure that the allergy
drops are working, may have to go
with the punctal plugs, feel like
I'm having some serious dry eye when
I work on the computer. Nose also
burns along with the eyes. I'm
pretty much shot after 2-3 hrs of
computer work, I'll have to
eventually tell my employer because
I'm no longer functioning.
I do still have a slight astigmatism
in the left eye, the right eye seems
to be a lot more painful then the
left. The right eye seems like it
wants to stay wide open, while the
left seems to be a little more
relaxed. Not sure if the astigmatism
could be responsible for my night
pain, probably more related to the
dry eye. After reading only a page
or so from a book my eyes feel like
those times I'd get caught up in a
good book and stay up all night with
it, exhausting.
I don't trust the technician's or
doctors from the clinic that I went
to and I'm not sure that I'll
actually be able to find an eye doc
that will be able to help.
,
xxxxxxxxxxxxx
January 20th,
2009
Most refractive eye surgeons put
their financial portfolio concerns
way ahead of any concerns for the
well being of the patient. This is
just another point that needs to get
out to the general public. I
personally cannot think of another
medical profession where this occurs
on such a widespread basis. We all
know of cases where cosmetic
surgeons (who were obviously
incompetent) ignored their patients'
concerns in order to further their
financial gains. But, these cases
are relatively infrequent.
When Lasik patients encounter great
difficulties and problems, they are
many times attacked for 'taking the
risk' as if they were ever really
informed of what they were getting
into. This, to me, is the ultimate
insult about Lasik, that patients
are blamed for not knowing that they
were lied to and the whole concept
of refractive eye surgeries, as they
exist today are only based on 'junk
science' anyway. Lasik is Third
World technology being used to
destroy lives and make a few immoral
bastards more wealthy than their
meager talents would have ever been
able to accomplish for themselves.
October 24th,
2008:
Prof. Lising’s
wife blinded by botched LASIK
Lesley Michaels
News/Web Editor
Lissa Lising – wife of Ian Lising,
assistant professor of speech
communication – discovered just how
wrong a regular medical procedure
can go when she was rendered
partially blind in her right eye
following corrective vision surgery.
Lissa Lising, an attorney, made the
decision to seek the surgery at
LASIK first in Hawthorne in
December, where she recalls being
rushed through a large group of
patients, eager to have the
procedure before the holidays.
Lising cites miscommunication and a
hurried schedule of patients as
reasons for why her surgery failed.
“The doctor never explained to me
what to expect from the procedure,”
Lising said. The procedure is
supposed to be done one individual
eye at a time, separated by a few
months for evaluation. Lising knew
nothing of this policy, since her
doctor performed on both eyes.
Lising also recalls the Web site
misleading clients into thinking it
is a painless, safe and hassle-free
procedure. Though Lising recalls
signing a disclaimer, it mentioned
nothing about machine malfunctions,
which raised suspicions. According
to Lising, a fail-safe stopper was
not installed on the machine, which
would prevent the needle from
penetrating through more than one
layer of her eye. When Lising was
approached by the machine, she was
unsure of what was happening and
hunched over into the machine in
nervousness, resulting in severe
cornea damage. “If a patient is
scared or unsure of what to do
during a procedure, a responsible
doctor should turn off the machine
and consult the patient,” Lising
said. According to Lising, the only
words the doctor expressed to her
upon seeing Lising’s pain was, “Oh
shit,” not words Lising or any
patient would be enthused to hear. A pt reports following lasik surgery, he is experiencing floaters,
glare, halos, severe starbursts and dry eyes. The pt stated the
floaters make it, 'difficult to see' and he is having trouble
driving due to the starbursts. The pt wa seen by several drs for
second opinions. One dr mentioned corneal imperfections and flat
corneas. The pt indicated he had done some research and found out
about central islands and thinks that is what the corneal
irregularities are. This report is for the left eye, the right eye
is being submitted under mfr # 1061857-2008-00081. The surgeon who
performed the lasik procedure on this pt indicated the pt did not
have central islands and has not been harmed or injured by this
event. The surgeon declined to provide any pt records. Pt records
were provided by one of the drs the pt saw for a second opinion. The
records indicate at 4 mos post-op bcva in the right eye was 20/15;
left eye was 20/15-2. Ucva in both eyes was 20/20. Pt has peripheral
vascular disease.
Manufacturer Narrative
Investigation including root cause analysis is in progress. A
supplemental mdr will be filed as necessary in accordance with 21
cfr 803. 56 when add'l reportable info becomes available.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1053952
Initial lasik surgery performed in 2003. Two weeks after surgery, i
experienced blurred vision & shooting pain in the left eye. From
there i have five corrective surgeries. I've been to four different
corneal transplant specialists. I am now facing a corneal
transplant, but the only problem is that the cornea will be repaired
but the pain from the nerve damage is irreparable due to numerous
surgeries. Now my only relief is to apply ointment & tape a gauze
bandage to it to get the eye toned for the following day. I struggle
daily with side effects like constant eye pain & other overwhelming
side effects. This has taken a toll on my emotions & quality of
life. For me, not a day goes by without wondering how much worse the
pain level can become with no medication for relief & also the
future cost incurred by this can become an issue.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1052127
Pt reports that she was not informed of the side effects of the prk
surgery states that five hrs after her surgery, she experiences
intense pain. She now has extreme dry eyes, has to close one eye to
drive because of halos. Pt states that she has to wear glasses to
see, however, the glasses makes her nauseated. The office where she
had the surgery promised to send her a pair of glasses and has not
as of yet.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1053909
In 2003, i underwent lasik surgery using the ladar laser for severe
hyperopia and astigmatism at the eye center. I was told i would at
least be seeing 20/40 the next day, which was not the case. After
going through several pairs of glasses and several months, my vision
finally settled. I cannot, however, achieve 20/20 in my right eye
anymore with glasses. I can't wear contacts because my eyes are too
dry now, and i can't tolerate the hard lenses. I have had problems
with halos and starbursts since surgery, and they continue now, 5
years later. I now also have a problem with some mild ghosting in my
left eye with certain lights. I also lost contrast sensitivity as a
result of the procedure. I do not drive at night unless necessary
because the oncoming headlights obscure the road. I did not read and
sign a consent form until after they had taken my glasses and given
me ativan to calm me for the procedure. During the procedure, dr had
a problem while using the laser on one of my eyes because i could
not hold my eye still, apparently, and he kept telling me over and
over to hold my eye still. Not so easy when he's yelling and i'm
nervous as hell as a laser is burning off part of my eyeball. I just
want others to know and understand the risks associated with lasik
surgery and for these money-hungry doctors to be more open about the
risks of this elective surgery.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1052128
Pt reports that after having laser/lasik surgery on both of her eyes,
she can no longer see and this has caused her not to be able to
obtain her driver's license.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1052885
Patient had lasik surgery in 1999-?-. In 2006, noticeable decline in
vision quality sudden began. In 2007, patient was seen again by
surgeon. In 2008, patient was told he had cone shaped corneas and
should be enrolled in the fda trial. No other recourse was offered.
Research dept's packet strongly insinuated that the lasik was the
cause of the now degrading eyesight. Patient requires glasses once
again and vision is constantly changing.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1052136
I have heard that the f. D. A. Is investigating lasik surgery and is
interested in pts that have had unacceptable outcomes from lasik
surgery. I had lasik surgery on both eyes approx ten yrs ago. Prior
to surgery, i was extremely nearsighted. The surgery overcorrected
my vision. In 1999, i went to another country for lasik to correct
the now farsighted condition. I had surgery on my right eye at that
time. The vision in my right eye is permanently distorted following
that surgery. I was told that my condition was a "fluke" and they
had no idea why my eye did not heal as expected. I now wear rigid
contacts which corrects the irregular surface of my right eye and
the farsightedness in my left. My uncorrected vision is improved
from the original condition but not well enough to drive or do
everyday tasks without contact lenses. The laser ctr.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1052221
In 2001, i had lasik, first on one eye and then on the other eye one
week later, at a clinic. I have struggled with dry eye ever since,
ranging from mildly to severely annoying. Despite having tried
punctal plugs, daily hot compresses, and doxycycline therapy, my
meibomian glands have never returned to normal function. Of course,
i have since learned this is considered a 'minor' lasik 'side
effect', most likely due to the permanent nerve damage wrought by
the microkeratome -hansatome- and excimer laser -visx- devices your
agency has approved for medically unnecessary purposes. I observed
my first floaters--signs of a posterior vitreous detachment--within
weeks of the lasik surgery - reported september 2001. This i have
learned is due to the high pressure caused by the suction ring used
with the microkeratome, which your agency has approved for medically
unnecessary purposes. I noticed double vision symptoms, especially
at night, soon after the surgery. I was relieved in 2002 that i was
able to get a prescription that seemed to relieve these symptoms.
However, over the next several years, i went in for several more
prescriptions, each proving a bit less satisfactory than the last.
Finally, in 2007, i was diagnosed with post-lasik ectasia, as my
corneal topographies showed the trademark sign of inferior
steepening, which accounted for my increasing cylinder and
increasing symptoms of double/multiple vision. I have thick corneas,
had stable refraction for 2 years, and measurements of flap
thickness with an artemis device showed no signs of a too-deep flap
thickness. In other words, i was a 'perfect' candidate, whose
preoperative topography -which showed ~0. 5 d of inferior
steepening- would probably not be turned away today despite the new
'stricter' guidelines being suggested. The reality of course, is
that nobody is a good candidate to have their corneal strength
weakened by a third by a microkeratome, for no medically indicated
purpose. However, this butchery remains approved by your agency. The
reality is that keratoconus remains poorly understood. At this
point, i'm still -barely- correctable to 20/20, so by some accounts
i'm 'normal', despite the fact that one can see 20/20 -or 20/16-
with significant irregular astigmatism that is anything but
'normal'. This has been known in the keratoconus literature for
years. Yet your agency continues to employ outdated visual acuity
measurements as the 'clinical outcome' measurement for approving
devices. This is convenient for the doctors, especially so because
'20/20' has been popularly misunderstood as 'perfect' vision, when
it is anything but. In the last several years, i have read with
interest about 'wavefront-guide' treatments, with an interest in
reducing my irregular astigmatism. I have been shocked and appalled
to see that devices marketed as being effective in reducing
higher-order aberrations have actually shown no data to this effect,
whatsoever. In fact, they merely reduce the amount of induced
higher-order aberrations. They have reduced hoas in patients with
initially high levels, but the reductions have been small. It's
shocking that devices known to increase higher-order aberrations /
on average/ are approved for general use. Should not people be
warned that their hoas--their quality of vision--/ will/ be reduced?
-though maybe not enough that they'll notice or care. Now i am
considering a topography-guided ablation, as this is the only
approach that has some track record of consistently reducing
irregular astigmatism and hoas by significant amounts. Indeed,
several doctors in another country have now several cases of
improving forme fruste keratoconus patients' best-corrected vision.
However, your agency has not seen fit to at least give humanitarian
approval to the laser refractive surgery devices that /do/ have a
record in reducing irregular astigmatism -e. G. The suite from ivis
technologies and/or the topography-guided options from wavelight-,
which is a legitimate medical purpose for refractive surgery. This
of course would not be lasik, but rather surface ablation. It is
unclear why lasik remains approved today despite the mounting
evidence that surface ablation is much safer biomechanically. So i
will have to leave this country, and visit europ instead, to have a
chance to improve my vision and likely also do corneal collagen
crosslinking, which was kept a well-hidden secret from us patients
-frequently along with their ectasia/keratoconus condition itself,
as doctors frequently don't diagnose what they can't effectively
treat- for many years, by your agency. Ironically, i have been
funded by the dhhs -nih- in the past, during my phd work. I work as
an optical engineer, developing adaptive laser scanning systems for neuroscience research. I've developed a cutting edge system, and
might well have moved towards consideration for future nih funding,
including the pioneer award. Of course, now it's difficult to work
in the dark, so my scientific career prospects are significantly
diminished. I am able to work for now under private funding. So, do
consider that your agency's behavior has not only been reckless, but
counterproductive. I hope you're ashamed. Dates of use: 2001.
Diagnosis or reason for use: good question! nominally a 'disease'
called myopia.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1052147
Following lasik surgery, i have experienced severe dry eyes and
fluctuating vision throughout the day as my intraocular pressure
changes. My vision fluctuates between approx 20/60 - 20/120,
requiring me to wear two different pairs of glasses depending on the
time of day.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1052148
The date of the "event" is the moment of realization of the problem,
not the date the lasik occurred. I had lasik performed about 10
years ago by a dr. My vision was excellent immediately, but began
deteriorating and i went in for a redo on one eye a little over a
year later. My vision continued to decline and i learned, it was not
correctable by glasses. I realized a few years ago that i was seeing
triple, but didn't know why. I didn't put it together with lasik
until 2007 surfing on the internet. The medical forum talked about a
pt whose triplopia was caused by lasik. Then i met an optometrist
who was familiar with triplopia. He examined me and confirmed he
couldn't do anything. He suggested getting legal representation but
i don't have the money to do so. He told me i will not be able to
pass a dmv eye chart exam. I didn't think there was anything i could
do. Then my daughter heard on npr that the fda is looking into lasik
issues and that's how i got here.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1052143
Lasik surgery on both eyes. Problems: evaluation for candidacy did not
include a thorough explanation of the effects of substituting
distance vision for close vision in an older person. I was told that
i would probably need reading glasses. Before the surgery, i was
able to take off my glasses -which i had worn for myopia since age
8- and see up close. I was able to read, to put on makeup, to cut my
toe nails, to see faces up close, to work on the computer - in
short, the vast majority of activities that one does. I could not
drive without my glasses or see distances. As a result of the
surgery, i could drive and see distances, but 99% of my daily
activities were now no longer available to me without reading
glasses. In addition, i could not see as well with the reading
glasses. I wore progressive lenses before; i wear progressive lenses
today. Eight years later, i am still angry and mourn the loss of my
vision every day. The issue is whether i was an appropriate
candidate for this surgery in the first place.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1078776
I had lasik surgery in 2001; a year later, my vision had worsened, so i
had to have it again; to this date; i cannot see anything without
rigid gas permeable contact lens that i can only wear for 8 hours a
day; i'm literally blind without these glasses; i only wish i'd
never gotten this surgery, because glasses don't even work. I'm
really sad and depressed about this.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1078775
I had lasik surgery in 2002. In 2008, i was advised i could have lasik
enhancements because my vision had changed. I now have moderate dry
eye in one eye and extreme dry eye in the other. I also experience
severe pain and discomfort when i try to read, watch tv, look at a
computer screen, or anything that requires me to focus. My eye
surgeon has placed a permanent plug in my tear duct. I use eye drops
every 30 minutes and get very little relief. It has made my life
miserable. I went to a cornea specialist last week. He suggested
taking fish oil and other multiple vitamins in hopes of making my
eye better. I was not explained the possible complications by my eye
doctor, and if i signed a consent form, it was just the same day and
just prior to the enhancement procedure. If i had known the
possibility of the severe dry eye, i would have never had the
procedure done. I am very upset with my doctor!!!.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1077192
In 2008, i underwent lasik on both eyes in the offices or dr. The next
day my vision was very blurry and i went back to dr and was told
that my flaps were too thin and that i would need an enhancement
surgery, but this may not correct the problem. When i asked why this
happened, i was told that, "it is just medicine" by dr. He also
asked the equipment mfr why all the machines told us i was the
"perfect candidate" for lasik and then this happened. They also had
no response. I believe the maker of the equipment is nadik. So now i
have gotten 3 second opinions and all agree that it may be fixable
with add'l ptk surgery, a yr of treatments.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1075511
Lasik complication. Following a lasik procedure i developed inflammation
and central toxic keratopathy -ctk- resulting in severe hazing
across the cornea, arge straea, and a blistering of the epithelial
layer. Betadine was administered even though i reported an allergy
to it. Hazing cleared, but halos in day time reflections and night
time lights are prevalent in both eyes. I am now 4 steps farsighted
-was 3. 5 steps near sighted- in one eye. Irregular astigmatism
persists causing ghost images and fuzzy vision. I believe this to be
a permanent condition after nearly 2 years.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1075441
The military used prk corrective laser eye surgery on both of my eyes,
and my vision in my right eye has become blurry. I have difficulty
reading emails on my laptop and cannot read the powerpoint
presentations during class. At night, i see starbursts around lights
which has made driving dangerous under these conditions.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1073789
Starburst and night vision problems since lasik eye surgery. Starburst
began immediately after surgery and never subsided. Vision seems to
be getting worse. It was a rare family history of glaucoma. Lasic
surgery tlc laser- whitten.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1074478
I had lasik eye surgery and have suffered numerous side effects in my
vision. Including a loss of peripheral vision in both eyes,
floaters, regions of depressed sensitivity in day light vision.
Night vision has degraded significantly and my vision has a
yellowish tint. In addition, i require daily eye drops for dryness
and get flashing migraine headaches on occasions. I have extreme
difficulty reading, and can not do technical work anymore. I deal
with eye pain and eye strain daily. Additionally, my eyes are very
sensitive to sunlight. Now i just go to college and live off the
proceeds of my house. I am also registered with the learning
disabilities center as visually impaired. Yet, my eye dr says my
vision is 20/40 and i am fine. I still need eye drops for dryness 2.
5 years later. Additionally, i feel that my eye dr who did the lasik
procedure is not being truthful with me and i have to pay for this
checkups every six months for the rest of my life. I am getting
ready to apply for disability.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1075348
Post operative data of a pt treated with the wavescan revealed an over
correction of +2. 00 diopter in the right eye and +3. 00 diopter in
the left eye at one month following treatment. Pt also is
experiencing dry eye. Patient's best corrected post operative visual
acuity in both eyes is 20/20.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1073784
Lasik eye surgery has caused me severe pain, damage and trauma. Every
day of my life it consumes me. Every day, all day, my eyes are dry,
sore and in severe pain. I use expensive eye drops and they only
provide a split second of relief. It is painful to do my favorite
activities, such as reading. It is painful to do my job as i work
from a computer. I am scared to go swimming, to the beach, or
snowboarding because they may only irritate my eyes further. I can
not go outside without sunglasses. I no longer think i can go back
to school because reading is so painful. It is painful to sleep and
painful to wake up. All day i live in complete misery. I am only 24
and am sad every day because i realize my life has been ruined from
this surgery. Today i saw someone wearing glasses and was wholly
consumed with envy. I wish i could wake-up from this nightmare. I'm
scared and have little hope. I don't want this to happen to others.
Thank you for taking the time to read this.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1069870
I underwent lasik surgery in late 2005. I have dry eye complications
from that surgery. I heard through the news about the fda hearing
today and was dismayed at the fact that only 140 complaints were
made. I need to know what i should do to let the fda know about my
complications. Please provide me with instructions. I am desperate
to have the lasik industry changed to protect future pts. (as a side
note, i was a healthcare admin for over 10 yrs, and before that a
scientific researcher- so i was a little appalled hearing that less
than 1% of lasik pts have complications- there is much research,
websites, etc. That prove otherwise). Your advice and direction will
be greatly appreciated.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1069871
I was eger to share my experiences once i found out about this hearing.
In 2000, i had lasik performed. In 2007, i began having sensations
of sand in my eye or sometimes, when very dry, glass in my eye. It
was very painful. I also had photophobia, and could not look at the
computer screen (i need to use for my job) or the television screen
without eye pain. Also, it was difficult to drive - in some cases,
when i would administer eye drops when my eyes were dry, the drops
would turn to almost a gluey consistency, and it was difficult to
see - somewhat like looking through wax paper - not good for
driving. This condition took over my life for the next yr, while i
went from dr to dr in search of a solution to the pain and
discomfort i was experiencing. Some drs said this condition could
not be linked to lasik, because it didn't occur until 7 yrs post-lasik
(interestingly, these drs also had lasik practices). However, 2 of
the ophthalmologists i went to (including two drs of the eye center
affiliated with tufts) did feel it was due to lasik. I now have the
boston scleral lens and it has helped me tremendously.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1069872
I don't know if the fda addressed the issue of inaccurate intraocular
eye pressures and intraocular lens calculations in post refractive
surgery pts but this had become a real problem. I am a board
certified ophthalmologist (cornea specialist) who performs lasik and
prk as well as cataract surgery. What most refractive surgeons omit
telling pts is that refractive surgery changes the curvature and
dynamics of the cornea. This makes intraocular pressure monitoring
(important in glaucoma diagnosis and treatment) and intraocular lens
calculations for cataract surgery difficult. If the preoperative,
operative and postoperative info is available, it can be used to
better calculate the true intraocular pressure and implant power.
Most refractive surgery pts are in their 20s and 30s but glaucoma
and cataracts don't become problems for decades later. By this time
the medical record is lost or unavailable. To help address this
issue, i have started a web-based refractive surgery database where
pts or their refractive surgeons can store this info for further
use. The website also provides info for pts and contains an
extensive list of references regarding this issue. Whether pts use
this database or not it is important that they obtain their medical
record for safekeeping. Please feel free to contact me with any
questions you might have. Thank you for your time and consideration.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1069873
Lasik 2007. Severe dry eye since, burning, unremitting pain, 4 tear
ducts plugged, blood serum drops, artificial tears, restasis,
depression, post traumatic stress, on work disability since 2008.
This experience has been beyond traumatic. They should ban this
procedure if beforehand, there is no way to determine if you will
get this. I had no previous history of dry eye or any underlying
conditions.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1071085
I am reporting a problem with my lasik surgery. I was told by the
doctor that lasik had a permanent effect. That was not true in my
situation, i had monovision and had a dramatic decrease in the
vision of both eyes 5 years after my surgery. The doctor still has
info on his web site that the procedure is permanent. I ended up
having the procedure done again at great expense. I would have
thought twice in the beginning if i had known that there was a
possibility of it not being permanent.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1069890
I underwent lasik surgery to correct farsightedness. I was initially
corrected with monovision. I was unable to see clearly from that day
on. I was told that it would take time for my eyes to heal and make
the adjustments for the monovision. So, i waited patiently but the
vision did not improve, instead it only got worse. In 2007, i was
given an enhancement to "delete" the monovision - that is what the
practice called the procedure. I had explained on numerous occasions
that i felt something had gone terribly wrong. I was given the same
song and dance every time i called in. When the flap was being cut
in my right eye they stopped mid procedure and started again without
explanation. I was told that this is no cause for alarm, but i am
hesitant now to trust anything they say or do. I am left with scar
tissue on my right eye that extends from the mid iris area to the
edge of the pupil and a little bit beyond. My distance vision in
both eyes was excellent before the procedure. Now i am left with
blurry vision in my left eye and my right eye is similar to looking
through a kaleidoscope. It is always very dry and painful, even
though i put drops in as directed. My night vision requires such a
heavy prescription that it distorts everything around me, causing me
to fear going out at night. My right eye no longer opens completely
because of the sensitivity to light and dryness. The depression
following this event has been the most devastating event in my life
so far. I am not sure where to turn for help, and am unable to think
clearly to even follow through and get some help. When i call around
for a second opinion i am told that i need to keep seeing my
original surgeon, and that makes no sense. I can tell that my eye is
getting worse, and i am certain that one day soon i will be unable
to see at all with my right eye.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1068318
Initial, bilateral, lasik surgery w/summit apex plus excimer laser for
moderate myopia both eyes w/mild astigmatism right eye. Within 4
months, vision was 20/200 bilaterally and blurry vision, halos,
starbursts and dry eyes experienced. In 2000, bilateral surgery
performed utilizing ladarvision to correct residual myopia and
astigmatism. At about 8 months later, surgery performed on right eye
utilizing ladarvision to correct residual myopia and regression. In
2001, surgery performed on left eye utilizing ladarvision to correct
residual myopia and astigmatism. The surgery(ies) resulted in
decentered ablations, irregular astigmatism, dry eyes, blurred
vision, halos, starbursts, loss of contrast and has made a negative
impact physically, psychologically & financially. (see scanned
pages).
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1067436
I had intralase, followed six months later by an "enhancement" with
lasik. I had been told i was a good candidate and any risks were
described as very minimal. Problems were evident immediately
afterward and i was told repeatedly they would clear up. Several
years later, while i have decent acuity, the quality of my vision is
poor. I suffer from issues with glare, light scatter, see ghost
images, halos and starbursts during the day. At night, i am almost
blind. I lost much of my ability to function in the world and am
also depressed and filled with remorse because i made the choice to
have this surgery. Yet, i imagine, i am characterized as a success
because i can read an eye chart from across the room. At my last
appointment with the physician who did the surgery, he said, he
remained terribly puzzled about my eyesight, acted almost as if he
didn't believe me, and said, "well, there's a lot we don't know
about eyesight. " if that were the case, i can't imagine why this
surgery is marketed so heavily.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1066827
A system operator reports a pt with overcorrections following bilateral
refractive surgery. This report is for the left eye, the right eye
is being reported under mfr report #3003288808-2008-00002. Pt
records were received and reviewed on may 28th. The corneal flap was
created by intralase and the pt received a conventional hyperopia
with astigmatism treatment with a planned monovision outcome. At 1
month post-op, this pt was overcorrected by -. 75 diopter in the
left eye. The left eye also exhibited a 2 line decrease in bcva. The
surgeon was contacted on june 10th to obtain data on the pt's
current status; however, the surgeon indicated, he was unwilling to
provide additional info, stating there was no harm to this pt.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1066036
Result of lasik procedure: left eye now has blurry vision, double
vision, halos, starbursts, epithelial ingrowth, floaters, dry eye.
Vision both near and far uncorrectable with glasses. Right eye:
double vision, halos, starbursts, floaters, dry eye. Distance vision
correctable with glasses.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1064755
This letter addresses my concern about the safety of lasik surgery. I
have practiced ophthalmology for thirty-three years. After taking
all the courses on lasik, i decided not to do the surgery. I believe
lasik surgery is not consistent with the ophthalmologist's
hypocritic oath of "first do no harm. " statistics on complications
could easily be manipulated by surgeons and i don't think their
reporting of complications can be relied upon. I think a few points
are more valid: it was reported in the last year in the literature
that lasik surgeons have an income creating the setting for
significant bias. A highly significant fact that seems to be passed
over without much comment is that the lasik flap can be easily
lifted for up to at least ten years exposing the pt to the risk of
dislocating and/or losing the flap when subjected to injury. A
recent article told of four such cases after ten yrs. When i have
explained this fact to hundreds of patients who were considering
lasik, everyone stated that it is enough reason not to do the
surgery. I explained to them that it's as if you had a circular
patch of skin incised and replaced and it could be easily lifted up
ten years later. Everyone is overwhelmed with this fact and say they
are convinced that they won't do the surgery. When i have seen
patients that have had lasik surgery with other doctors, none of
them were aware of this fact. We are playing russian roulette with
these patients, hoping statistically that they won't be hit in the
eye. We are also playing this roulette game hoping beyond all hope
that they don't get infection, but we all know infections happen. I
went to a meeting at the last conference in 2007 which was concerned
with how commonly senior citizens eyes become irritated from dryness
and the use of multiple preservatives over the years. I asked the
panel at the meeting, many of whom are lasik surgeons, why aren't we
more concerned about the damaging effects of lasik which causes dry
eye and damaged corneal nerves. They elected not to answer the
question. I think we have a panel already in this country that is
ideal to give you the answer to the problems with lasik. The panel
consists of the thousands of ophthalmologists who chose not to do
this procedure knowing they could make a half million dollars more
per year. I think you should send a questionnaire out to all the
ophthalmologists, especially those who don't do this surgery and ask
them why they don't do it. I have seen other examples of where the
fda allows higher risk manipulations of the eyes when it clearly is
against the patients' interest. Two of these examples are allowing
all-in-one chemical solutions for contact lenses without advising
the patient to rinse off the detergent and disinfectant with saline.
These patients are soaking their eye all day in these two irritating
chemicals. The three most commonly used solutions do not recommend
rinsing. Another pandering to patients is the following of no-stitch
cataract surgery, even though medicare has shown the doubling of the
incidence of infection in the eyes in the last ten years since
no-stitch surgery has been initiated. This is not likely a
coincidence. The three examples cited in the letter, i. E. , lasik
surgery, all -in-one contact lens solutions, and no-stitch cataract
surgery are all examples of pandering to patients vulnerable
instincts in an effort to promote a "wow" factor, rather than a
healthier outcome. I have seen over the last thirty-five years in
ophthalmology a steady trend within the profit side of medicine
taking precedence over "first do not harm".
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1064265
Received lasik surgery in 2007. Since surgery i have had much trouble
adjusting to new vision including loss of near vision that was not a
factor previously, even with glasses -pre-surgery- on for
nearsightedness. This effect was not explained to me before surgery.
I experience ghosting in both eyes, more severely in right eye. Both
eyes experience starbursts, daybursts, halos, and glare. I
experience double vision when i look to my extreme left that i did
not have before surgery. I have had a noticeable increase in
floaters in both eyes, but especially severe in the right eye. Both
eyes are noticeably drier than before surgery. I never had any dry
eye before lasik surgery, not even once. Distance vision is
noticeably not as clear and sharp as before surgery with glasses.
Overall vision is significantly reduced and less functional than
before lasik surgery. Overall quality of life is significantly
reduced as i have experienced and continue to experience digestive
issues and psychological disturbances that directly coincided with
lasik surgery.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1064245
I had lasik surgery and since then i have not been able to work for
more than a half a day. I see double at times. My vision goes blurry
and then i can't see up close or anything in the distance. I can no
longer drive at night because of the halo effect. In low light
areas, i strain my eyes so hard that i have pain. I had mono lasik
and it has completely screwed my life up. My doctors office which is
the lasik vision institute keeps telling me that i have extremely
dry eyes and that it will clear up, but i have had no improvement
and it seems to be getting worse. This could ruin my career and my
life. When they tested my eyes before the surgery and found out how
dry my eyes were, they should have turned me away, or at least
informed me of the serious problems that were occurring because of
dry eye syndrome. I am paying for surgery that has ruined my life. I
don't know how the fda can continue to let these doctors perform
this surgical procedure that ruins peoples lives. I am devastated
over this and don't know what i am going to do.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1134043
I had bilateral lasik eye procedure to correct distance vision. I awoke
the next day to find that i had 20/20 distance vision, but i had
lost my near vision. That was not the case prior to surgery and i do
not remember being specifically warned of that possibility. I also
developed dry eye, floaters, halo & glare that i was told would go
away within a few months healing time. They did not. I also was not
offered the option of only having one eye done at a time or was the
option of monovision correction offered. I am an ultrasound
technician by trade and i depend on being able to see near/computer
and now i am burdened with having to wear glasses and having to pay
off a huge amount of loan because i didn't want to wear glasses in
the first place !! diagnosis or reason for use: improve distance
vision.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1134023
Severe dry eyes from lasik with wave technology. For therapy, currently
using nocturnally heavy lubricant eye ointment of 41. 5% mineral
oil, 56. 8% white petrolatum with eye mask to preserve humidity.
Daytime use of lubricating eye drops.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1128165
Permanent visual problems resulting from lasik procedure. I was 20/20
with contacts prior to the procedure, and had no eye problems. I now
suffer from higher order aberrations as well as dry eye. I have lost
my best corrected vision and can no longer wear contact lenses, due
to discomfort. This procedure has severely impacted my quality of
life.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1125904
In 2008, i was undergoing a lasik procedure. The doctor had just
started the procedure on my right eye. The first part of the
procedure required the use of a microtome cutter that cuts a flap in
eye tissue to expose the cornea for the laser treatment. However, in
the process of using the microtome, i experienced sharp very intense
pain, the doctor made a comment like - "oops", or "oh know"- he
explained that "i have to stop, i cannot do laser on you just now,
we must do it later-, he then said that he needed to allow me to
heal and that i had to come back the next day -friday- and saturday
so he can see the healing. On friday, i was seen by another dr. He
looked at my eye and i asked him what happened the day before, i
also told him, that during and after the procedure, dr never told me
what happened and since i was sedated during that procedure i was
not thinking clearly. Friday, i asked this other dr what happened.
This dr. Told me that dr. Had cut or nicked my cornea. I told him my
eye hurt and i could not see out of it. Dr. Said that dr. Wanted to
look at my eye on sunday. I am reporting this because i am a former
bio medical engineer with experience investigating pt device
failures. I will be seeking medical help from insurance co. Next
week, however, medical literature shows that cornea cuts, and
abrasions often leave permanent eye damage, i have been in much pain
for two days, i am shocked and dismayed by the unprofessional
behavior of my surgical doctor, i was injured because either the
device malfunctioned or the doctor made mistake during the
procedure. Thus, this is a reportable event.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1125943
Lasik eye surgery resulting in partial blindness in right eye.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1125983
In 2003, i had lasik surgery. Since that time, i have experienced
extreme dry eyes and eye pain. On many days i cannot see much at
all. I have had medical treatment for the dry eyes and pain with
minimal success; the eyes will feel somewhat better for a short time
only to become near debilitating again. Dates of use: #1. 2003, #2.
2004. Diagnosis or reason for use: #1. To improve vision. #2. I
don't actually remember why they "enhanced" by eyes.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1120483
Prior to the lasik procedure, a treatment table from the wavescan 3. 9
software was generated that resulted in an induced astigmatism of 3.
2 diopter in the right eye and 1. 2 diopter in the left eye. In
addition, the right eye received an over correction of 2 diopters.
Pt's uncorrected visual acuity is 20/40 in the right eye and 20/30
in the left eye.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1111792
Received lasik laser surgery on my eye. Since that time, my eyesight
has deteriorated terribly and i have permanent blurred and foggy
vision. Diagnosis or reason for use: to improve eyesight.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1108803
I underwent custom vue lasik procedure in 2005. After the surgery, i
have experienced the following problems in my left eye:
approximately 1-2 months after the procedure, my tear ducts left eye
completely closed and my left eye is constantly tearing. I have
undergone surgery to try to open up the tear ducts, but the surgery
was unsuccessful. Over the past 2 years, my vision left eye has been
getting progressively worse and i have been diagnosed with ectasia
-thinning/warping of the cornea-.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1119026
A voluntary medwatch was received from the fda. Info indicates a pt
experienced difficulties following bilateral lasik surgery. The
report is for the left eye, the right eye is being submitted under
mfr report # 1061857-2008-00169. This pt reports experiencing blurry
vision, halos, starbursts and dry eyes 4 months following initial
lasik surgery. The following year an enhancement was performed on
the left eye to address residual myopia and regression. One year
later, a second enhancement was performed on the left eye, this is
to correct residual myopia and astigmatism. This pt stated these
surgeries resulted in decentered ablations, irregular astigmatism,
dry eyes, blurred vision, halos, starbursts and loss of contrast.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1119083
A voluntary medwatch was received from the fda. Info indicates a pt
experienced difficulties, following bilateral lasik surgery. This
report is for the right eye, the left eye is being submitted under
mfr report #1061857-2008-00170. This pt reports experiencing blurry
vision, halos, starbursts and dry eyes 4 months following initial
lasik surgery. The following year an enhancement was performed on
the right eye to address residual myopia and regression. Eight
months later, a second enhancement was performed on the right eye,
this is to correct residual myopia and astigmatism. This pt stated
these surgeries resulted in decentered ablations, irregular
astigmatism, dry eyes, blurred vision, halos, starbursts and loss of
contrast.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1104239
An optometrist reports a hyperopic pt that is unhappy following
bilateral lasik surgery. This report is for the left eye. The right
eye is being reported under mfr report number 3003288808-2008-00008.
The pt was a +5. 00 diopter pre-op and at 1 month post-op was +1. 75
diopter which regressed to +3. 00 diopter at the 7. 25 month post-op
exam. Bcva remained the same as pre-op (20/20) and ucva improved
from 20/200 to 20/100-. The pt reported difficulty driving at night
due to glare and 'can't see as well as before the lasik'. This pt
has a history of esotropia, and during the post-op period, the pt
reported the left eye was 'turning in'. Additional info from the
optometrist indicates this pt had strabismus and was likely an
amblyope. The optometrist also stated the pt was becoming more
presbyopic which was causing the pt additional frustration.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1104240
An optometrist reports a hyperopic pt with a poor clinical outcome
following bilateral lasik surgery on the right eye. This report is
for the right eye, the left eye is being submitted under mfr's
report number 3003288808-2008-00011. A 6 months post-op, this pt
exhibited a 1 line decrease in the right eye and ucva went from
20/50 pre-op to 20/200 post-op. Additional info has been requested.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1103503
I had wavefront lasik surgery in 2004. I was severely overcorrected and
had to have a second surgery 4 months later in early 2005. I have
had severe dry eye ever since. I use drops almost every hour -systane
nonpreservative vials- and get up at night 2 to 3 times to put drops
in and still wake up with red, irritated eyes. My upper eyelids are
always swollen and i get irritated eyes if i put makeup or
moisturizer to close to my eyes. I have a lot of discomfort and get
stabbing eye pain with headaches 2 to 3 times a month. It take two
days of advil to stop the pain. I believe i am also uncorrectable.
My optometrist hasn't specifically told me this but there is no
change to my vision with different lens. I have to wear reading
glasses to see within arms length now and didn't right before the
surgery but needed to right after the surgery. I had to wear my
husband's reading glasses to see at all until the next surgery. I
was unable to read or write or drive a car for 4 mos.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1082580
A surgeon reports one pt with decreased bcva following lasik surgery.
Follow-up with the surgeon indicates the patient's vision has
returned to 20/20, the topographies look well centered, the
epithelial irregularities have cleared with the use of dry eye
medication and punctal plugs. The surgeon also stated the pt has not
been harmed or injured. The surgeon did not provide any info
regarding this patient's pre-op bcva measurement and has declined to
provide any other info regarding this pt, and requested we not
contact him any further regarding this matter.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1088924
Alcon received a voluntary medwatch from the fda. The pt reports
following lasik surgery for severe hyperopia and astigmatism, she is
experiencing a loss of best corrected visual acuity (she cannot
achieve 20/20 in the right eye), halos, starbursts, dry eyes,
ghosting and loss of contrast sensitivity. The pt also reports she
no longer drives at night because the oncoming headlights obscure
the road. In addition, the pt stated she had difficulty holding her
eye still during the procedure,although the dr repeatedly instructed
her to hold still. The surgery was 5 yrs ago, and the pt still has
symptoms.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1089204
Alcon received a voluntary medwatch from the fda. A pt reports chronic
problems and disability following lasik surgery. Pt records were
received and reviewed. This pt was treated for a monovision outcome,
the left eye being treated for distance vision, the right for near
vision. During the post-op period, the pt experienced dry eye
issues, trouble with depth perception in the left eye, difficulty
reading newsprint, halos at night and blurry vision. The surgeon
noted early dry macular degeneration approx 5 months post-op,
blepharitis throughout the later post-operative period, and noted
the blepharitis and dry eye issues were affecting the pt's vision.
Following an enhancement on the right eye, the pt reported an
improvement to the near vision, but the mid-range was not good. The
pt continued to have near vision difficulties throughout the post-op
period. At the last post-op exam provided, the pt experienced a
decrease in bcva in the right eye from the initial pre-operative
measurement.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1080832
Rptr reports that he had laser surgery in 2005 and now he has double
and blurring vision and has to use many eyedrops. Reporter states
that dr will not see him, or honor the warranty that he has. In oct
2006 rptr states that he had to have plugs inserted for dry eyes and
saw a specialist and was told he had a refraction and his eye was
the shape of a football. In 2008, pt had "lasik surgery touch up".
Rptr states that he had 7 f/u visits and was told that he had scar
tissue and an astigmatism and would have to wear an eye patch on his
right eye. Pt states that he now has to have glasses to see after
paying thousands of dollars for lasik surgery.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1081320
A surgeon originally reported a patient with topographically-observed
"central islands" (corneal irregularities) following a custom myopia
with astigmatism laser procedure. The patient's outcome following
the initial procedure was reported under mfr report
#1061857-2007-00332. An enhancement procedure was performed on a
different laser platform from the initial procedure. This report is
for the pt's outcome following that enhancement procedure. At approx
2 months post-enhancement, the pt's bcva is 20/80, a 4 line decrease
from pre-enhancement and ucva is 20/400. Notes on the pt's records
indicate, "right cornea has +1/2 reticular haze centrally with
pericentral tough supero-temporally".
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1081426
In the midst of my lasik surgery on my right/first eye. The dr
announces that "we are dealing with a free cap". After he completes
the surgery on the right eye that lasts almost half an hour, he
tells me that "there must have been some mismeasurements". We can
continue and run the risk of the same thing happening to the left
eye or he can make some adjustments and hope we don't have to repeat
free cap. At the time i was too traumatized to understand the full
meaning of a free cap and knew i would never come back if i left at
that moment. Fortunately, the left eye turned out fine.
Unfortunately, there were not appropriate markings to replace my
free cap in its correct position. During the next 12 months, i had 5
further surgeries to turn, stretch, stitch the free cap in its
proper position. In the end, the amputated cap was removed. I now
have to wear a hard contact to get any vision in that eye. It's very
painful, irritating and stressful. The reason i originally had the
procedure was to not wear soft contacts. I cannot get the hard
contact out without a plunger and it is always painful.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1081413
Lasik enhancement, 2 more subsequent enhancements, irregular
astigmatism.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1081298
Post operative data of a pt treated with the wavescan revealed an over
correction of +2. 00 diopter in the right eye at one month following
treatment. Pt's best corrected visual acuity is 20/25-2.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1078776
I had lasik surgery in 2001; a year later, my vision had worsened, so i
had to have it again; to this date; i cannot see anything without
rigid gas permeable contact lens that i can only wear for 8 hours a
day; i'm literally blind without these glasses; i only wish i'd
never gotten this surgery, because glasses don't even work. I'm
really sad and depressed about this.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1174023
I had custom wavefront lasik surgery in late 2006. The treatment used
an alcon ladar 6000 excimer laser system made by alcon refractive
horizons. I had an adverse outcome, with under-correction and
increased central curvature errors in both eyes. My doctor reported
topographical irregularities to alcon, including a "significantly
steeper central area". In addition to details of my specific case,
the doctor also reported that the facility had experienced a
substantial increase in the overall number of enhancement treatments
required compared to their prior alcon ladar 4000 system. According
to my doctor, alcon did not provide any info then and no further
info was received from alcon until the ladar 6000 device safety
alert was issued on february 21, 2007. I was given one additional
enhancement treatment in the left eye in 2007 and two additional
enhancement treatments in the right eye in 2007 and 2008. These
procedures were successful in removing residual refractive errors
but, since custom treatment was regarded as "off-label" for
enhancement procedures, no attempt was made to resolve my high-order
aberrations. I continued to complain of blurry vision, double
images, glare and halos. More debilitating, though, were headaches i
experienced in any vision-intensive activity, particularly with high
detail and/or motion. Even routine activities like shopping became
difficult. I continue to receive regular eval and monitoring from my
doctor, but all treatment options through the local facility have
been exhausted. I then decided to pursue other treatment options at
other facilities, both regionally and nationally. I made numerous
attempts to ask questions of alcon. Since alcon's device safety
report mentioned topographically-observed central islands, but did
not describe any of the island parameters, i asked alcon what range
of topographic parameters they included in their use of the term
"central islands". Since the device safety alert mentioned problems
at other surgical centers, i asked for references to other doctors
who might be doing follow-up eval and/or treatment of alcon ladar
6000 patients. Since alcon had collected considerable info from my
personal medical records through contact directly with my doctor, i
asked alcon to provide a summary report -without any patient's
personally identifiable info-, including typical central island
parameters, possible changes over time, and any additional
treatments that had been tried at other facilities. The telephone
number alcon had provided in the fda recall was not even the right
department at alcon, so it took a number of days for alcon to decide
who i should contact. Alcon's eventual response was not from any
medically qualified staff person, but rather from their legal
department, stating that they were unable to answer any of my
questions. Alcon has also intervened and interfered with my attempt
to enlist the services of another medical facility. Finally, when my
doctor asked alcon many of the same questions, alcon also declined
to respond to the doctor. As of 2008, alcon had not responded to
even one of my questions or any of my doctor's questions. We know
that alcon collected but, now that i need help from alcon to better
understand the adverse impact of the ladar 6000 system, the info
flow has stopped. Not only did alcon injure me through their ladar
6000 system, but now they are further adversely impacting me by
continuing to withhold info that might facilitate my further
treatment and recovery. Dates of use: 2006 - 2007. Diagnosis or
reason for use: custom wavefront lasik.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1167205
Lasik: i first had lasik in 2000; had a second procedure that fall.
Most recently had lasik in which the cornea was manual scraped
because it was noted that i had map-dot-dystropy. These procedures
have been done in an attempt to eliminate halos and starbursts, and
increase vision acuity. As of this date, no improvement. I also have
had dry eye since the original procedure. Tried drops and tear-duct
plugs; neither worked. Both upper and lower ducts have been
cauterized. Perhaps some improvement, but still very dry eyes.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1164204
Despite having good vision, i was induced to have lasik surgery to
strengthen my distance vision for athletics - softball, golf,
refereeing-. I was told i would have to wear "cheaters" to read.
After the surgery my distance vision was improved, but it was
difficult to read event with cheaters. After complaining i was told
i was a good candidate for enhancement surgery-ck-. I was given
contacts that they said would stimulate what vision would be like
after enhancement. Both my distance and near vision were excellent
with the contacts so i agreed to the enhancement. In the meantime,
however, i had to have an aortic valve replacement. During this
surgery, a clot went to my brain causing a stroke. I recovered from
both the replacement and the stroke and was able to see except for
peripheral vision to the left. I was given the ck enhancement with a
resultant blurriness in both my distance and near vision. Now, a
year after the enhancement and a huge expenditure and multiple pairs
of glasses, i can only focus on images that are about 20 feet away.
My life is ruined. I have always been very active physically but now
can only shoot baskets in my driveway. I was a 3-handicapper in golf
and can no longer break 100 and have to play with a spotter. I can
only type and read with computer font magnification. It's like
living behind a muddy windshield. Since i can see about 20 feet, the
constant eye tests are a joke. In effect, i'm 20/20 blind. I need
20' golf tees, a step ladder and two caddies.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1158866
I had lasik eye surgery in 2001 with the eye surgeon's encouragement of
how well i will see post-op. Well, the vision did improve greatly,
but with a price to pay. I have suffered from severe dry eyes ever
since the surgery. It's 7 years later and i am still suffering from
the "uncomfortableness" of dry eyes. Now, though, i have to wear
glasses again because my corneas are swollen to the point of causing
blurred vision again. I just went back to my optometrist to get some
new glasses and he said he had never seen a lasik pt's eyes vision
drop this much in only 2 years from my last glasses change.
Recently, my primary care doctor did an eye test on me with my
glasses on and i failed that test. This is so scary. I am back to
not being able to during the day, and even worse, is my night
vision. I am scared to go out at night and drive, as all lights have
a star effect. Very difficult to see. Two years ago i was started on
restasis and had punctal plugs put in both eyes. The restasis did
not help at all. The plugs in my eyes were also a disaster, as their
tops poked and scraped into my eyes. My eyes were extremely red,
painful, raw, and sore with those plugs in. One fell out about 3
months later. The other one just fell out about a month ago and i am
so thankful to have it out of my eye. It was 2 years of pure hell
having that thing scraping my eye. My current symptoms include:
feeling like i have sand in my eyes, extremely dry eyes all the
time, pain, progressive blurred vision. At night, during my restless
sleeping, i wake up every hour or so with my eyes in pain and even
more dry than during the day. I literally pour artificial tears into
my eyes all night long. When i had this procedure done, i don't
remember being told that this dry eye syndrome was a risk i was
taking. I wish i had never had it done. And that says a lot from
someone who wore glasses all her life and was so excited to think of
having surgery to help me see better.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1157865
Image from lasik surgery, dr. The intralase flap cutter, and the alcon
6000 laser platform. When are you going to do something about lasik
surgery? how many more people are going to be hurt?
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1157867
Lasik surgery in 2008. Punctal plugs three months later. Dry eyes
continue to date, cannot work a full 40 hour work week due to pain
and discomfort. Difficulty seeing in low light conditions. Began
taking anxiety and depression medicine about 4 days after surgery.
Was hospitalized overnight for chest pains. Turned out that it was
likely a side effect of the depression meds, but at the time i
thought i was having a heart attack.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1157868
I had lasik to correct my vision and now i have extremely dry eyes. I
am using restasis - prescription, prophylactic antibiotics,
artificial tears, genteal gel, muro 128 ointment. I do eyelid scrubs
and eyelid warm compress twice per day. I have to wear goggles to
ride my bike or do any outside activity. I can stand heating or
air-conditioning if it's too near me. During my screening, i
discussed the fact that my eyes were slightly dry. I asked if the
dryness would increase after lasik. The doctor told me that they
tested my tears and i wouldn't have any problem. The literature
provided to me said that permanent dry eye was rare after lasik. I
trusted my doctor and the literature provided. I am so miserable
now. I have never achieved a point in 2 years where i felt that my
eyes were stable and comfortable. I may have to undergo another
surgery at some point to dry to correct erosions of my cornea. I
have a condition known as abmd -anterior basement membrane
dystrophy- which lasix center did not screen for. The dry eyes cause
erosions and the abmd makes it very difficult for my eyes to heal. I
feel that i wasn't given the correct info before making my decision
to have lasik, and i will be paying for it for the rest of my life
-monetarily and in the pain i constantly am suffering-. Lasik center
definitely should be required to provide candidates with all of the
risk factors prior to surgery.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1153463
Eight yrs ago, i had lasik surgery on both of my eyes. Since then i
have had blurred vision. Headaches, extremely impaired night vision
and dizziness. The doctor who performed my surgery was let go which
i later found out was due to his poor results. I was misinformed on
many levels regarding the outcome and expectation of this procedure.
I have since been back to that same practice where i have had 3
additional surgeries, and it has been highly suggested by this
practice that i have a 4th. I have spent thousands of dollars on
other physicians only to be told i am stuck like this. I am a mother
of two small children and this is ruining my life! i was not a good
candidate for this procedure as i have a large pupil size. I am
angry, frustrated and helpless.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1151983
I had lasik surgery in 2007, monovision. My eyes felt wonderful but i
did not adjust to the monovision. Six months later, on approx six
months later, i had an enhancement on my left eye. A week or so
later, everything went downhill. I had and still have severe dry
eyes. It sometimes completely disables me. I have to keep my eyes
shut and i cannot socialize, it shuts me down because of the extreme
discomfort. It is now 2008, and it is still the same. I have started
restasis and doing my 8th week. Praying that this will help me. I
have figured out that the weather has something to do with it. The
air quality. I just don't know what to do to take care of it before
it affects me. I can sometimes go 3 weeks comfortably, but then it
starts again and it is uncomfortable for quite a few days. I guess i
really screwed up!.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1151948
Lasik -excimer laser- microkeratome created two short flaps. Doctor
made two attempts in dominant eye. Lasik microkeratome cut two short
flaps in dominant eye leaving two permanent scars causing streaks
from every light source. Lasik procedure was aborted. Event in 1999.
Reported here because saw an article about the web site, and so you
can have better statistics.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1162023
Rec'd a voluntary medwatch report from the fda. The rptr/pt indicated
experiencing visual difficulties following bilateral custom
refractive surgery for myopia. This report is for the right eye, the
left eye is being reported under mfr report # 1061857-2008-00181.
Following surgery, the pt reported large starbursting and halos
under low light conditions; reduced low light contrast sensitivity;
difficulty driving at night; corneal irregularities; central
islands; high increase in floaters; and posterior vitreous
detachment.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1135383
For the first 2 weeks after lasik, my eyes felt a little dry, but
overall good. However, over the next few weeks, the dryness kept
getting worse. By week 6, i had severe lasik induced nerve damage
dry eyes. My eyes were bone dry and the pain was unbearable for the
first 10 months post-lasik. I could feel the pain with every blink
of every day. Even closing my eyes provided minimal relief. All the
eye doctors could do was tell me to keep using artificial tears, put
me on restasis, and put plugs in my puncta -the drains of the eye-.
These things provided minimal relief. The pain was so intense with
so little relief from existing therapies that i found myself
researching suicide options on the internet. Prior to lasik, i was a
happy family man with a good job. To think that i could find myself
in this type of position because of lasik, an unnecessary fda
approved procedure, was beyond belief. I am now over 2 years post-lasik
and i suffer from senseless, permanent disabilities incurred from
lasik. There are many things that i no longer can do such as being
in a room with moving air from ceiling fans, heating vents, or air
conditioning. I can only work limited hours due to the chronic post-lasik
pain that i endure. I suffer from chronic eye pain that intensifies
as the day goes on. I would write more but i don't think anyone in
the fda who has any decision making authority reads these reports
because if they did, i would expect that they would feel a shock to
their conscience that the fda continues to allow people's eyes and
lives to be ruined by lasik, a senseless, non-medically necessary
procedure. I've heard lasik physicians compare lasik to other
cosmetic procedures. That's absurd! if somebody has a poor outcome
with breast augmentation, they can still go to work and/or drive at
night. A person's eyes are their most vital sensory organ. If you
damage a person's eyes, you damage that person in the most significant way. While it's too late for me and many others, it's
not too late for future lasik pts. I request that the fda serve the
public that you are entrusted to protect rather than serving the
lasik industry.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1134043
I had bilateral lasik eye procedure to correct distance vision. I awoke
the next day to find that i had 20/20 distance vision, but i had
lost my near vision. That was not the case prior to surgery and i do
not remember being specifically warned of that possibility. I also
developed dry eye, floaters, halo & glare that i was told would go
away within a few months healing time. They did not. I also was not
offered the option of only having one eye done at a time or was the
option of monovision correction offered. I am an ultrasound
technician by trade and i depend on being able to see near/computer
and now i am burdened with having to wear glasses and having to pay
off a huge amount of loan because i didn't want to wear glasses in
the first place !! diagnosis or reason for use: improve distance
vision.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1134023
Severe dry eyes from lasik with wave technology. For therapy, currently
using nocturnally heavy lubricant eye ointment of 41. 5% mineral
oil, 56. 8% white petrolatum with eye mask to preserve humidity.
Daytime use of lubricating eye drops.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1208863
I had surgery in lasik center in 2008, i was farsightedness using 1. 50
glasses i went to have a consultation to see if i was a candidate
for surgery, they said i was the perfect candidate and that it will
be done in less than 10 minutes. The day of the surgery, a lady
doctor who was going to perform the surgery told us that we may need
reading glasses after the surgery, she never told us that i won't be
able to see up to 8 feet or that i will have this problems that i am
writing below. Discomfort of pain, blurry vision, dryness, glare,
halos, starbursts around light, itching, scratchiness, light
sensitivity, i can hardly see my face now, i cannot perform my job,
i have been buying almost 30 pairs of glasses trying to fit one to
my needs and my life, it is not the same any more. I am very
depressed, grieving, desperate, they have ruined my eyes and my
life, and the life of my family. Please help me. I don't know what
to do now. I feel blind, i can do nothing.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1202339
I received lasik on both eyes in 2006 at the laser eye center. Dr of the
eye consultants performed the surgery. I experienced severe dryness
after the surgery. I also experienced problem driving at night and
watching tv. Some days were good and some were bad. When things
started getting really bad, i went back to dr. After some tests, he
concluded that my vision distortion is caused by a condition in the
cornea, something he termed as 'keratoconus'. He also mentioned that
my eyes could be susceptible to eventually suffer this condition,
but most likely the progression got elevated by the lasik. He has
signed me up to participate in a study called 'collagen
cross-linking' of the cornea - at institute - where they use a
combination of vitamin b2 and uv light to strengthen the corneal
muscle. This study is my only hope. If this does not work out for
me, then i would have to consider a corneal eye transplant according
to dr. I seriously regret having done lasik. I am hoping that this
complaint will help fda to help future potential lasik candidates to
seriously consider all options before opting.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1196352
A surgeon reports one pt with decreased bcva following bilateral prk
surgery. Surgeon stated he is puzzled by this pt's outcome, all
other results were 'wonderful'. This report is for the left eye, the
right eye is being reported under mfr #3003288808-2008-000015. Pt
records were rec'd and reviewed. Surgeon's preoperative notes
indicated, "long term should be stable, 50/50 chance will need
enhancement", which was discussed with the pt. The pt rec'd a prk
procedure which is not an approved indication for this device and
mitomycin was applied to the stroma directly following ablation,
which is not an approved indication for this drug. Records indicate
the pt noted seeing multiple images even with glasses prior to
surgery, and at one month post-op the pt reported polyopia (multiple
images), which continued throughout the postoperative period. Four
diopters of exophoria at near were noted and the pt commented,
"sharp pain on temporal side of the left eye while adducting". Pt
comments included, "difficulty staying focused" and "shift in focus
ability". During the postoperative period, the records indicate
fluctuating refractions, discomfort, burning and foreign body
sensation. At approx one month post-op, bilateral lower lid punctual
plugs were placed to address dry eye symptoms. Add'l treatment for
dry eye during the postoperative period included artificial tears
and restasis. At 6 months post-op, the left eye experienced a 4 line
decrease in bcva. Add'l info provided by the site indicates this pt
rec'd an enhancement procedure approx 6. 5 months post-op. Add'l
info ha been requested.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1193647
In 1997, i had lasik surgery performed on both eyes. I had an
enhancement in 2005, 1998 on my right eye. I now suffer from
debilitating starbursts, halos, poor contrast and depth perception,
and severely limited low light vision. Where i once was able to
drive freely at night, i can no longer get around even on foot. Even
in daylight i often mix up my own children with other people's
children from distances as short as 6 feet away. I also suffer
severe headaches from intense eye strain and the use of pilocarpine
drops -. 5%-. Pre-existing conditions were: congenital nystagmus,
myopia, astigmatism, night blindness - able to drive at night. My
pre-operative readings were: measurement od os ou vcc
20/20020/40020/200 bscva 20/40 - 20/50, 20/10020/40 - 20/50.
Refraction. -10. 00, -5. 75 x 010, 20/80, -10. 50, -6. 00 x 155.
20/200, 20/75. My current visual acuity is around 20/60 - 20/70 ou.
Although i visited dr's office numerous times to seek help with the
symptoms mentioned above, i was always told that everything was
perfect and that these "side effects" were temporary and would go
away, which they never did. In 2001, i finally gave up on dr and saw
another lasik practitioner who informed me that i had decentered
ablations, due to my nystagmus and that i was contraindicated for
lasik at that time. I later learned that i also had significant
higher order aberrations and was also contraindicated, due to the
degree of my myopia and my pupil size.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1194159
Cv treatment induced an unexpected +4 cylinder on a male pt.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1190204
Ectasia in both eyes due to lasik surgery.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1187773
Ophthalmologist performed lasik surgery too soon after stopping wearing
rgp contact lenses. He said my eyes were stable only 3 weeks after
giving up these rgp lenses. They were not. As a result, my eyes
continued to change drastically for several months after the
procedure. I went from being myopic, about 8. 00 diopters to
hyperopic. He also left me with very significant striae in my
cornea, especially the left one. He tried to "iron out the wrinkle"
the next morning. The visual lack of acuity continued for a long
time and he would not tell me what was wrong with my vision. I
finally was compelled to go to another ophthalmologist in the area,
who said a special procedure had to be done immediately to try to
get the striae out. I then had to go under this procedure which was
not covered by insurance. This helped to a large extent. I could
not, however, get a refraction for glasses or contacts for about 4
yrs that would correct my vision. I now have to wear rgp lenses once
again. Eyeglasses cannot be prescribed as they will not work.
Therefore, i can't correct my vision - for example when my eyes are
inflamed or irritated- unless i'm wearing them.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1183965
I had lasik surgery 4 yrs ago. I have been suffering from chronic dry
eye since. When i first returned to the surgeon who performed the
lasik surgery, he informed me that my surgical incision had healed
beautifully, and that he did not have an answer as to the constant
red eyes. After two yrs, and 200 bottles of visine later, i finally
went to another dr who informed me that i had been suffering as a
result of the lasik surgery. We gave our college aged son the lasik
surgery as a birthday gift the same year!.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1177611
Not sure of exact dates, but had lasik done about 18 months ago. I now
have severe, irrepairable dry eye syndrome. The pain is
debilitating, intense, and continual. I have been advised by dry eye
specialists that the condition is permanent. How will i live when i
get too old to apply the eye drops i have to use literally every 5
minutes? the worst is the massive and intentional lying regarding
risks. The sales person told me that they had only ever had two
individuals suffer significant issues post op. The surgeon himself
misrepresented the risk. Dr. Himself told me verbally that the only
instance of permanent injury was when a lady accidentally poked
herself in the eye with a garden tool and peeled the flap back. He
specifically told me the risks of severe side effects were ''very
remote". I suppose dry eye syndrome is considered a "minor"
complication. I should have noticed earlier that dr. Himself has yet
to discard his spectacles. This quack of a money whoring surgeon
should be censured at least, and preferably shot between the eyes
for intentionally lying to me regarding the statistical risk profile
of this procedure.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1232234
There is epithelial ingrowth in both eyes and i can not see clearly near
or distant both. Refraction test shows cylindrical, as well as
spherical number in both eyes. All my jobs are suspended since the
operation i. E. For the last 2 mos. Overall, the irregularities in
the corneal surface is suspected to be responsible for all the
existing problems.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1230095
Approx 6 weeks after lasik surgery, i noticed that points of light at
night are doubled -e. G. , instead of one red traffic light, i see
two-. Surprisingly, i don't notice much of the haloing and
starbursting that are usually described as lasik night vision
problems. I have also noticed that i experience double vision in my
right eye during the day time. This is most noticeable when trying
to read a ruler or tape measure. All the graduation lines are
doubled and i have to close my right eye to determine the correct
measurement. I have also noticed a dramatic increase in the number
and density of the vitreous opacitities -floaters- in my vision.
This increase also occurred at approx 6 weeks post surgery.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1226129
VISX Laser: Severe contrast, low light issues from lasik.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1224224
Lasik surgery- non wavefront- roanoke, va at eye care & surgery. Adverse
event- g. A. S. H. - glare- arc of light- starbursts- halos- at
nighttime & in low light settings.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1216517
Dr. Performed my lasik in 2007. After the procedure, i developed chronic
dry eye. I hadn't had this problem before the procedure and was not
warned about it prior to the procedure. I went back to dr. Norden
and he inserted plugs in my tear ducts and explained that women over
40 tend to have this problem. I would liked to have been warned
beforehand so i could have made a more informed decision about this
procedure. Now, over a year later, i still have plugs in my tear
ducts and wake up in the middle of the night with difficulty opening
my eyes and have to put drops in to be able to sleep. My eyes are
sore, very dry, and puffy in the morning and i'm concerned about the
long-term effects. I have been given a prescription for restasis but
am afraid of forming a dependency. I thought that after all these
years this procedure had been perfected and i knew all of it's
shortcomings, and i'm very disappointed with the results. With all
the problems, i would at least have hoped that i would have come out
of it with perfect vision, but that was not the case. Dr. Offered to
do the procedure again to fix my vision, but i'm afraid my eyes will
just turn to dust if i take him up to it.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1215203
I had lasik eye surgery from dr. In 2006. It was the biggest mistake of
my life. Here is a list of my concerns: - my last checkup occurred
last year, and i still remained at 20/15 on my right eye and 20/20
on my left eye. This is very misleading as things over 20 feet are
blurry. They're especially blurry in medium to low lighting. I had
no idea that my eyesight was definitely going to be worse
afterwards. I thought since 20/20 was very likely, my vision could
remain perfect at far from it. My vision also fluctuates depending
on how much rest i get. I believe it's because the more i rested i
am, the bigger my pupils are. Bigger pupils lead to seeing more
through untreated parts. -they only treated my eyes partially and
did not warn me of this. The treatment zone simply did not cover my
entire eye. I have big pupils. The cut did not go outside of my
pupils but within it. The outer area of my pupils remains untreated.
I was not warned of this. I just cannot understand how they can get
away with something like this as it has severely affected my vision
for the worse. -i was not warned that i was going to get a permanent
scar on my eyes. I believe it plays a big part of my blurred vision.
-i was not warned that my night vision was definitelly going to get
worse. I was very shocked the next day to see that my night vision
definitely got worse. This should not be a surprise. I was simply
warned about the possibility of getting starbursts and halos. I have
a severe case of both. Based on the size of my pupils, they should
have told me that the likelihood was high. -dry eyes are a constant problem for me. I've experienced loss of sleep and lack of sleep,
due to extreme dryness that wakes me up or severe crust formations
that did not exist before surgery. I was not aware that there are
tests to determine how dry your eyes are. This should be a mandatory
test. I have to put several eye drops a day- probably for the rest
of my life. This is very costly, embarrassing, and bothersome. - i
had red eye for about one month on my left eye. I had no idea that
this could happen. It was very embarrassing to have it when i wanted
to prove to co-workers and friends that lasik was safe and
recommendable, but was i simply showing them proof that i made a
mistake. The reputation of my judgement has probably been
significantly damaged. -it takes a long time focusing on different
distances. If i'm reading something and look up to something, it
takes seconds to focus on it. This was always instant before. I was
not warned of this. -the stats provided by the media and the ads are
absurd. My surgeon asked me if i was glad to have done the surgery
the day after. I said i was. He may have put that on record. No
one's asked my how i'm doing now. Based on my own personal survey of
people having done the surgery, most have regrets.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1213589
I had lasik in both eyes in 2008. I had high prescription of contacts at
a -8. 50 in left eye and -9. 50 in right eye. Very high prescrip. My
surgeon, dr diagnosed me with dry eye before i had surgery when he
was doing some tests. I shouldn't have had this surgery. After
surgery, i saw like a freak immediately, though mostly clear, my
world has turned upside down. My floor is crooked, my walls are
stretched, circles aren't round anymore, my eyes were changing
constantly being even one whole diopter different, i was
overcorrected, and eventually when i got stern enough, he finally
told me i had both decentered eyes. A nightmare i still live with
everyday. What was not told to me until i gathered enough
information from 15 docs or so, -most of whom would not tell me,
only found out because i insisted on my records, that is, if they
chose to put what it really was, i found some do not even write what
they should on the charts- i found out i had epithelial ingrowth,
blepharitis, corneal haze, corneal swelling, post-op astigmatism
that the laser gave me!, irregular flaps, and some more i probably
don't remember right now. One month after surgery, after my lying
doc said all i had was overcorrection, -i knew he had to be lying- i
went for a second opinion at laser center and saw another dr od, who
worked for dr(third)- he told me i was fine, i just saw freaky
because i had such a high prescription and it would take a long time
to heal -more lies- then said i too had corneal swelling- of which
at that time i didn't know you have to treat with steroids. He did
not treat me, told me to see my surgeon in the next week and sent me
on my way. Well, because he didn't treat me, and i got to my surgeon
too late, i now live with unbearable permanent damage from the
corneal swelling seeing a ghosty line around everyone and everything
and have no 3dimensional vision all due to him not treating me- i
had an episode on the following month, where everything i saw had
changed. Mind you, on top of the freak world i "already" lived in
with moving, crooked walls, distortion, crooked floor, etc. -and you
know what dr(second) saw in my charts that i had dlk-therefore i
even had pred forte on my counter and could have taken it till i got
to my surgeon if "he" didn't "want" to treat me, and i wouldn't be
living like this, had he told me what was going on and how i could
fix it or event that i should see my surgeon asap today!, if he
wasn't going to help! good thing i have one honest doctor i can now
turn to. But the damage is done and not repairable, and believe me
if you had to live like this, you wouldn't want to. It's god awful
existing this way and being "forced" to see things so wrong. After
thousands of dollars spent, i have contacts that help some, but
guess what i will never see normal again. Well, i guess i must add,
that i do have severe dry eye, of course halos and starbursts, and
of course, loss of contrast in a big way. I also have corneal
thinning, because i also have only 219 microns left in my left eye
and not much more in my right. I fear ectasia, cataracts, corneal
transplants if corneal swelling continues, which i've already had
again this year! lucky i know now, to go in right away and my new
doc "does" treat me. I miss my beautiful world. Can't seven see my
own face straight; even with contacts. My nose moves because it is a
different shape in one eye than the other, as well as all things
being different shape, too. I went in thinking i'd have a miracle,
and ended up hating life, trusting none, but one doctor, and having
my life turned upside down and never being able to get past it,
because it's always "in front of me"! imagine! could you endure?
going through a day in life, is no fun and very scare, every day!
you know what, even the words on this screen typing to you, do not
go straight across, dipped in the middle, up on one end, down on the
other and swerved. Can you even fathom living like this? the machine
used on me, was an alcon ladarvision 4000, and if i went to a second
opinion doc, and i wouldn't let them known who my surgeon was,
they'd just ask what was the machine used. I bet it's a faulty
machine on top of finding out the doctor has a bad reputation. I've
also learned of people who went to well world renowned docs and
still had irreversible damage. I just don't think lasik should be
done, period! i was responsible for deciding on this surgery, but
the truth is, i trusted the doctors know what they are doing and
would never do a surgery that would harm, if they knew it did, and i
found out the worse, which is they do know it harms! included with
that is all the hype that's it's virtually a piece of cake, and
foolproof, to find out later the ruth is so many are harmed, -i've
met those with transplants, now and who are blinded- and none of us
should have to live like this. I had a great future ahead. Had, is
how i feel. L:ife will never be the same! thanks for listening.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1212026
Complaint description: my optometrist of 20 years, dr at vision center
recommended another dr to do my lasik surgery on my eyes. When i
asked which office he was at, dr(first) told me that he was out of
the office. I had eye surgery in 2008 at the office with dr(second).
Immediately that night, i experienced problems. When i tried to call
vision center, we only got a recording. There was no emergency
number listed on the space for phone numbers on the papers that they
sent home. When i paged dr(first) there was no response. At 1am on
the next day, a friend drove me to the er. They too tried to page
dr(first) and tried to call dr(second) and vision one. All the
doctors could do for me at the er was to prescribe a pain pill and
sedative, -which should have been prescribed by second dr to begin
with-. The er visit cost almost $500. I continued to have problems
and went to see dr(first) my optometrist. He really didn't know what
to do because he is not a surgeon. He said i should just keep
putting drops in my eyes and it would get better. When dr(first)
took the contact bandages off, my right eye got worse immediately. I
called up dr(first) and he said that i needed to give it time and it
would get better. My eye was too painful to be able to see and i was
not able to work. After a week and a half i returned to dr(first)
and by that time i had serious issues with my right eye. After
talking to second dr by phone, i was referred to an eye surgeon,
another dr. I went to dr(third) and he had to perform surgery to
lift the flap on my right eye and clean underneath it due to growths around and under the flap. My eye was very painful all over again,
and i was not able to see clearly or work. I continued to see him a
few times a week for several weeks. It was at that time i learned
dr(second) does not live in town. He lives in another state. That is
the reason why he could not see my when i developed problems. If i
had known that he does not live here, i never would have used him as
my lasik surgeon. Now after several mos of going out for
appointments with third dr, i still can not see out of my right eye.
It is like looking out of a blurry dirty film. It can not be
corrected with lenses or glasses. I have to have another surgery on
nov. 6 and dr(third) says i will need another in 4-6 mos. So far i
have been billed for thousands of dollars and that does not include
prescriptions or patches that i had to buy. That does not include
the surgery on approx five months later, or any future visits to dr.
Foulkes. I have had to miss weeks of work due to pain and loss of
vision. I have had to take off work to drive out to hinsdale to see
dr(third) many times. Lasik surgery performed by second dr on
original date. Follow up care by dr(third) to try to correct
problems. On ten days later, corrective procedure performed by
dr(third) to lift flap of right eye to clean underneath. On the next
day, follow up care dr(third), two days later follow up care
dr(third), three days later follow up care dr(third), the following
month(two days later) follow up care same dr, five days later follow
up care same dr, three days later follow up care same dr, a week later follow up care same dr, the following month follow up care dr,
eighteen days later follow up eye surgery to clean under flap in
right eye by dr, three days later follow up care same dr.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1039137
I had lasik surgery to correct my vision. I now suffer from extreme
severe dry eyes. I use drops every 1-4 minutes in each eye. The
surgeon still has me using the sterile drops and has me taking
various supplements. He has also permanently plugged my tear ducts.
Our monthly bills for drops and supplements! i am also in constant
pain. I cannot drive at night or see well at dark. My day activities
have been altered drastically. I cannot do so many activities due to
eye pain, and needing to stop and use drops every 1-4 minutes. My
vision is fuzzy at all times, except for about 5 seconds after
administering the drops. I cannot read road signs or see faces. Of
course i fear the worst, which is blindness. Because of pain and
extreme light sensitivity i have to always wear dark glasses. As far
as i can tell from my records, i was never asked or tested for dry
eyes prior to the surgery. I thought i was suffering alone until the
recent reports have been highlighted. My husband, parents, and
relatives are chiropractors. They have me on the best supplements
for dry eye, but nothing has helped much. If you know of anything
else out there, i would be most thankful for your advice.
Respectfully. I don't know the name of the machine used, but the
date was 2007.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1039138
I flew to have perform lasik on both eyes. Since, today's date is 2008
and going on 9 years, my vision has been distorted, i have dry eye
syndrome, decentered flaps cut from the microkeratome blade, and an
uneven laser reshapement, permanently thinning out my only corneas
further ruining my vision for life. I have spent, trying to return
my vision to normal with no luck. I have traveled around the world
and have seen the best doctors, all with no fix in line. My own dr,
has lawsuits and has continued to lie to myself and my family about
the lasik procedure going wrong, very wrong, horrifically wrong. I
want a complete investigation of my dr's lawsuits, his lies, and his
unprofessional ways. He has harassed my family, attempted to sue us
to the tune -he failed- because of my website that warns the masses
about lasik and lasik doctors like him. I want justice. Lasik will
never be safe because it is still unpredictable surgery. One person
it works for, and the next go blind or have complications beyond
control to deal with. At least with contacts or glasses, you can get
by with sane vision. The consent form is a joke at best. It does not
give the consumer all of the known and unk symptoms, side effects,
and long -term problems that it should be giving them. It protects
doctor while injuring the pt. Complaint and investigation on: the
vision center.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1039140
In 1992, i lost my vision after refractive surgery - rk. In early
october i had gone to a "free" seminar to gather info before i saw a
dr. I had pre-existing scar tissue on my left eye but dr said "no
problem", and we proceeded with bilateral refractive surgery. I did
not have good vision from the start. I was told that "things have
not settled down yet. We can always perform an enhancement. " i
struggled with my duties at home and work. In 1993, i went to
another city to see another dr -a referral from dr(first)-. He
performed a prk on my left eye with later plans to surgically
improve the right eye. At that time second dr told me that dr(first)
made the cuts in my eyes too deep and too long. My left eye now had
vision worse than pre-prk and was covered with scar tissue from the
laser. In 1995, i went on medical leave from my surgical nursing
position and had a corneal transplant. During that year, i filed for
disability retirement. In 1996, i went to jury trial -case, medical
malpractice. I was the victim made to look like a perpetrator. We
lost the case and threw ourselves into debt. Dr(first) told me i was
a good candidate for refractive surgery, that i would have good
results and could throw away my glasses. He never told me there was
no turning back from this surgery. He never mentioned the star
burst, night blindness, double vision or painful dry eye. He never
mentioned that i would not be able to care for my three children. I
live the nightmare every day and cringe when i see the same
advertising today as when i had my disastrous eye surgery. Dates of
use: 1992 - 1993. Diagnosis or reason for use: rk cutting device and
laser for prk procedure.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1039141
Event: bilateral lasik refractive surgery to correct nearsightedness.
Outcome: initially corrected to 20/25; about 3 months after surgery,
regression began, causing nearsightedness to return and requiring
use of expensive custom contact lenses to achieve 20/20 vision.
Night vision severly damaged: corneal surfaces healed with a
non-smooth surface, causing severe higher order aberrations -hoas-,
which cause visual disturbances, including: large starbursts when
looking toward any light source, such as car headlights. Multiple
-more than 20- images of bright objects. Much poorer ability to
discriminate objects in dark or dim rooms. Night vision disturbances
and hoas cannot be corrected with glasses, or with most types of
contact lenses. Require expensive custom-made large diameter rigid
gas permeable -rgp- contact lenses. Annual expense for rgp lenses
and special cleaning solutions: for first pair of lenses -including
professional fees- with duplicate lenses for each lens. Annual cost
of cleaning solutions and devices; dry eye caused by lasik causes
discomfort when using corrective contact lenses.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1047150
My lasik experience: after initial surgery in 1998, then enhancement in
1999, my vision in both eyes, uncorrected was 20/20. This was truly
a miracle for those of us so dependent upon contacts and glasses. I
remember disposing of all my old contact lenses and extra cases. No
more lens cleaning, scrambling for glasses at night, occasional
discomfort etc. This visual quality of life lasted 9 months. Then,
gradually the sight in my right eye deteriorated to 20/100 by late
1999. I also noticed declining vision in my left eye, just to a
lesser degree. My lasik process from the outset was being handled by
both my local od and surgeons from the nearby medical school clinic.
Neither could understand this change but both concluded that in
early 2000, i should undergo a 2nd enhancement on both eyes. The
outcome of this 2nd enhancement made no improvement and further
thinned my cornea to less than 250m r and 275m l. Eventually,
ectasia or keratectasia became the diagnosis and rgp lenses were
prescribed. My average best corrected post lasik vision with a rose
k rgp in the left eye is 20/25 and a boston scleral lens in the r is
20/40. Typically, i am able to wear my lenses with reasonable
comfort up to 15 hours daily. Unsuccessful results: unsuccessful
results as in my situation, tend to lead to various complications
such as ectasia or keratectasia, dry eye problems, depth perception
difficulties, and in general, intense disappointment. Most likely,
the real reason for unsuccessful outcomes in the pre lasik screening
and preparation process was not adequate and the surgeon was too aggressive in the degree of correction. Also, as is the case in all
vocations, there are some physicians who are simply not qualified.
Another contributing factor to complications after lasik surgery can
occasionally be the result of obsolete or faulty calibrated
equipment. Lastly, is the fact that fundamental mistakes are made
even by the most qualified doctors. I believe and again emphasize
that if attentive pre lasik screening is adhered to, reasonable
margins for error are considered, and detailed checks and balances
are built into the lasik process from beginning to end,
complications as a result of lasik surgery can be significantly
mitigated. When you get to the stage many of us are in, anger,
frustration, and major disappointment is natural. We ask; why did
this happen? what should i do? what will be the final result, i. E.
Will i end up blind? although still very difficult, i try to
objectively negate or offset many of these disappointments and
concerns by concentrating first by simply coping but secondly and
most importantly, focusing on the prospects that better treatments
for ectasia, kerataectasis, and keratoconus are being constantly
developed and in the not too distant future, a long-term viable
solution will emerge. Detailed history: 1998: preop exam, manifest r
-7. 00-1. 75x030 20/20. L -6. 75-2. 25x162 20/20. On the following
month: two week status post lasik. Visual acuity without correction
20/25 r and l. Manifest r -0. 50 sphere 20/20. L -0. 75 sphere
20/20. In 1999: three months status post lasik. Visual acuity with
out correction 20/20 in the right eye, 20/25 on the left eye.
Manifest r -1. 00 sphere 20/20. L -0. 25-0. 75x130 20/20. On approx
three months later: six months post lasik. Visual acuity with out
correction 20/50 in the right eye, 20/25 on the left. Manifest r -1.
00-0. 25x010, l -0. 25-0. 75x140; 20/20 vision in both eyes. On
approx six months later: visual acuity with out correction r 20/60,
l 20/40. Manifest r -1. 00 sphere. L -0. 75-1. 00x145, 20/20 acuity
in each eye. In 2000: 24 hr post lasik enhancement. Visual acuity
with out correction 20/20 in the right eye, 20/20-1 in the left eye.
Manifest r plano-0. 50x050 and 20/20 vision l -0. 25 sphere 20/20.
Two wks post lasik enhancement. Visual acuity 20/20- right and left
eye. Manifest r plano-0. 50x055, l-0. 50 sphere 20/20 vision in both
eyes. In 2000: three months post lasik enhancement. Visual acuity
without correction 20/25 in the right eye, 20/20 in the left eye.
Manifest r plano-0. 75x055 20/20 vision and l plano-0. 50x140 20/20
vision. On approx three months later: six months post lasik
enhancement. Visual acuity without correction 20/30 in the right eye
and 20/25 in the left eye. Manifest r -0. 25-1. 00x065 and l -0.
25-0. 50x130 20/20 vision in both eyes. In 2001: one yr post lasik
enhancement. Visual acuity without correction 20/100 in the right
eye and 20/50 in the left. Manifest r plano-3. 50x086 and l-0. 25-0.
50x130 with 20/20 vision in both eyes. On the following month: preop
for lasik enhancement #2. Visual acuity without correction 20/100 in
the right eye and 20/32 in the left. Manifest r was -0. 50-3. 25x081
and l -0. 25-0. 50x 130 for 20/20-3 in the right eye and 20/20 in
the left. On approx seven months later: visual acuity without
correction was 20/100 in the right eye and 20/32 in the left.
Manifest r -0. 25-4. 25x094 for 20/25 acuity and l -0. 50-0. 75x115
for 20/20. On sixteen days later: lasik enhancement #2. On the
following month: two weeks post lasik enhancement #2. Visual acuity
without correction. Was 20/50 in the right eye and 20/25 in the
left. Manifest r plano -0. 75 x 040 with a variable response for
best corrected visual acuity of 20/50 and l plano -0. 75x135 for
20/20. On approx three months later: three months post lasik
enhancement #2. Visual acuity without correction was 20/50 in the
right eye and 20/25 in the left. Manifest r -0. 50x1. 00x060 for
20/40 acuity and l pano-0. 75x 135 for 20/25 visual acuity. Since
the enhancement #2, continuous central pek worse in the right eye
than the left. In 2002: five months post lasik enhancement #2.
Visual acuity without correction was 20/100 in the right eye and
20/30 in the left. Manifest r -0. 75- 2. 75x35 for 20/20 visual
acuity. Irregular steepening in the central cornea, mild pek,
confirmed central comea ectasia. On the following month: contact
lens fit od that achieved 20/25 vision. One and a half months later:
change in visual acuity in the left eye. Manifest refraction l plano
1. 75x 50. On four weeks later: initiated rgp fitting of the left
eye with visual acuity of 20/20.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1039109
I had lasik surgery performed in 2005. A year's long problem with dry
eye syndrome, itching of the eyes, there were days i came home from
work and wanted to rip my eyes out, they itched so bad. Had lots of
blurred vision, was put on restatsis for 6-9 months. The hospital
where i work -i'm a veteran- put permanent plugs in both bottom tear
ducts to help with dry eyes, but this created a lot of fluid
build-up at night to where my vision was even blurrier. My provider
who performed the surgery eventually told me to blow dry my eyes
every morning. What a joke, i paid him 4,000. 00 to have all these
problems. If i had this to do over again, i would never have had
this procedure performed.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1039110
Lasik surgery that has resulted in ghosted vision, reduced night vision,
halos, reduced vision in dim light, and loss of contrast in dim
light. Diagnosis or reason for use: nearsighted -4. 25, no longer
able to tolerate contacts, glasses cause.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1039111
Had a lasik procedure completed that resulted in reduced vision in my
left eye and improved vision in my right eye. In the process of
creating the corneal flap, the entire cornea came loose and had to
be stabilized with a contact after the procedure. The complication
was labeled normal, and my claims of blurred vision and poor outcome
were not taken seriously by the facility that completed the
procedure. However, i am a nurse and had a chance to speak with an
ophthalmologist regarding the procedure. The ophthalmologist
attributed the poor outcome entirely to the error of the
unsuccessful flap creation in the left eye for the laser. Lasik
surgery in 2007 laser.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1039112
I had lasik surgery in 2006, and have suffered significant eye health
issues ever since. While my eyesight is good, i developed superior
limbic keratoconjunctivitis -slk- and severe dry eye syndrome.
According to webmd, "it is believed that slk is present secondary to
superior bulbar conjunctiva laxity, which induces inflammatory
changes from mechanical soft tissue microtrauma. " ophthalmologists
treated the slk with drops and environmental modifications for a
full year with no success. I have since reluctantly had additional
surgery - conjunctiva resection on both eyes, but am still
experiencing problems. My ophthalmologists say they cannot begin to
treat the dry eye syndrome until the slk is brought under control.
Unfortunately, the lack of an adequate tear film aggravates the slk.
I believe this vicious circle was directly caused by lasik surgery.
Neither the surgeon nor the surgical center where i rec'd the lasik
adequately warned me of the dangers. Although it was not bothering
me at the time, they measured my tear production, determined i had
dry eyes prior to surgery and started a course of restasis. Knowing
what i do now, that alone should have disqualified me from the
procedure. I urge the fda to mandate stronger criteria to disqualify
people for this procedure and to promote additional pt education
prior to surgery. Dose or amount: bilateral surgery, frequency:
once.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1039113
I received lasik eye surgery two years ago. Since that time, i have had
three "touch-ups" due to poor results. These poor results include: -
blurred vision - dry, itchy eyes - a feeling that something is "in
there" - extreme sensitivity to light - fear of night driving.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1039114
After effect: night halos, especially while driving; dry eye; noticeable
weakening of correction within 18 months of procedure. Glasses
required for night driving. Pre-procedure: despite requests, i was
never able to speak directly with the operative surgeon until
moments before the procedure and then, only just briefly. There was
no substantive contact with the surgeon, ever, even post surgery.
Also, pre-procedure, i was shuffled between two optometrists in the
office and had trouble getting consistent info about the details of
my correction. It felt like a mill; i was just one of the masses. P.
S. Despite the problems, i feel that lasik requires a risk-benefit
assessment for each pt. I suffer these after effects, but if i had
the option to choose the procedure again, i would probably do it.
The benefits outweigh the after effects. For others this may not be
true. It is an assessment that each individual must make. If i could
do anything differently, it would be to interview more
facilities/physicians, instead of just going with the one who i
thought had the best record. I should say, also, that i chose
mono-vision so that one eye sees far away and the other sees close.
I do not need glasses for reading or distance, only for driving at
night due to halos. I do have some trouble with intermediate
distances, say three to four feet.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1039121
Lasik surgery flap not sufficient to proceed in left eye, device did not
fit eyelid. Redid surgery in several months, 2006, using another
technique. Painful dry eye resulted immediately in both eyes from
original lasik surgery and has not remitted fully, although,
improved with daily use of expensive eye drops - cyclosporin.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1039122
I was overcorrected in my left eye as a result of wavefront prk with the
visx excimer laser. Not only that i have, terrible side effects in
both eyes -gash- which greatly affect my night vision and vision in
low light situations. Mild dry eye is also problematic. For a
procedure that was supposed to make my life easier, it has made it
much more difficult and complex on a daily basis. I so very wish
that i could go back to my vision with glasses. Not a day goes by
that i am not reminded of the adverse events following my prk. Date
of use: 2006.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1038013
Laser vision correction surgery. An inexperienced surgeon or defective
machine cut flap too deep leaving a bulge on my eye. Second surgery
in 2005 -by the same surgeon- to remove bulge, damages the cornea
and leaves me with the uncurable eye disease pinguecula. The surgeon
contends i have dry eye.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1038108
Dear sir/madam: please be informed that i had a lasik surgery in late
1996 at the hospital by a dr. I have written you a certified letter
on 04/28/2008 in reference to the problem, and i have also written
certified letters through the years to medical entities, and
political officers. Dr did a malicious act by masking half of my
cornea and created fluids under the cornea flap to conceal the
immediate results. I have been all over the world to see if
something can be done to correct my cornea, but nothing can be done.
In my letter to you, i have enclosed tomographies, so you can see
that only a human hand could have covered half of the cornea and
create fluids under the flap. Currently, my cornea is irritated, i
can't wear contact lenses, and i can see triple images. I hope your
agency shall investigate this matter and bring dr. Mcdonald and
other doctors like her to justice. If doctors like dr are left
unchecked, the problems doctors injuring patients will not go away,
and we will have an injured handicapped and unhealthy society.
Sincerely.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1038117
Lasik, prk eye surgery left eye prk, right eye lasik. Extreme difference
from l to r eye. Left eye also still has bad astigmatism, had to get
prescription reading glasses for one eye to slow down headaches. I
paid the extra per eye, for lifetime touch up. After waiting 1 yr, i
went back to see if they could balance out the eye better and was
told no. Unless they get worse than 20/40 they would not do it. That
was not told to me at the time of surgery. Why pay the extra money
then? i am now very light sensitive. As my md told me, photo-phobic.
The need for sunglasses is all the time and i have even had a few
episodes that were so severe that i had to pull over when driving.
It is interfering with my work. Floaters or what i would term as
dirt floating around in the eyes, which is really loose blood
vessels. I was told that these would go away after a few weeks as
they started shortly after the surgery. It's been a year and a half
and there's still a lot of them.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1038120
After lasix surg: i had preexisting ectasia which went undiagnosed by
the dr. He took 2 thermal photos on two separate appointments that
now we know clearly show red, thin areas of the cornea. After the
first surgery, i could not see as well as before surgery and dr kept
saying it will get better. Never did. He did what he called "an
enhancement" which he said would re-center my vision, removing even
more tissue. He was going to do a third procedure "enhancement" and
was stopped by the head of the eye dept at the out of town hosp
where the surgery was done. I see halos, star bursts and now have to
wear contacts to hold the cornea down. Dry eyes is a huge problem.
Night driving is pretty much not possible except in emergency. Long
drives to parents and friends is not something i can do anymore.
Lost 30 peripheral vision as well. Just about ruined my life and dr
never said, i'm sorry. No help at all.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1038128
I had lasik surgery two years ago. Mostly it has been perfect, but my
night vision is awful now. It used to be very good. It's almost
scary to drive at night. Especially when it's raining. I never had
that problem before. It's like when the sun shines just right into a
camera and the light spreads and blocks stuff out. Also i see the
halos around duller lights. My vision during the day is fantastic.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1038131
Lasik surgery. I was not a good candidate having a size 7 pupil and -10
1/2 refraction with astigmatism. My night vision is impaired and
have to stop driving at night. Have starbursts and very dry eyes
which affects vision. Had extreme pain after surgery and 4 months of
very little vision. Ten years later i have macular degeneration in
one eye which has further debilitated my sight. The surgeon said i
was an excellent candidate which was clearly not the case.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1038099
Following lasik surgery, i have had problems with serious dry eyes.
Every morning i must use eye drops and most nights as well. In
addition, in the dark light objects have sunbursts.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1038103
I was talked into having rk-radial keratotomy- on my eyes by dr. He
said, he never had a problem with any of his surgeries and
guaranteed me a successful outcome. After the surgery, however, my
eyes became very fatigued and sore. He said that i was reading from
the twenty-twenty line on the eye chart and that this problem is in
my head. He offered no support or guidance in this matter
whatsoever, and practically dismissed me. I was shocked. Now i was
left with sore, tired, fatigued eyes and no answers, since this was
a new procedure in our area. So i began a journey to try and find a
solution. This journey has taken me to numerous prominent eye
surgeons. The have prescribed soft and hard contact lenses, glasses,
performed ck-conductive keratoplasty-, lasik twice, and nothing has
really corrected the problem. The pitfalls of corrective eye surgery
need to be honestly discussed by these eye doctors, not covered up
by misleading advertising and hype. Thank you for your time and
concern in this matter.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1038104
Lasik surgery. Extreme pain in eyes lasting 2 weeks. Had to stay in
darkened room for a month. Since operation every thing is dim. Very
difficult to drive at night, halo and sparkler effect from lights,
extreme dry eyes.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1038106
Lasik surgery was performed with less than desired results. The patient
requested clear distance vision and the results were clear close-up
vision with maintained distance vision requiring corrective lenses.
Lasik was performed again on the left eye with better results, but
still less than desired. In 2007, cataract surgery was performed on
both eyes to obtain desired results.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1036129
Was supposed to have lasik surgery, but had prk because the md said i
did not have enough cornea. Prk in early 2008. That night the
bandaid lens fell out of my left eye and formed a corneal abrasion.
After many visits back to the md, and he stating everything looked
good for about a month. I visited another md because my eye looked
like it was going to fall out of the socket. The 2nd md stated i had
a terrible infection behind the cornea. He treated me aggressively
for about 2 weeks. No improvement with many eye drops and daily
visits to the md. The md stated that he had to do an emergency
corneal transplant or i might loose my eye. I have a permanent
disability 20/70 in my left eye. I continue to have discomfort and i
am recovering from shingles of the eye. My outcome for vision is not
good. I had 2 other md visits and they both agreed regular lasik
surgery was much better, and i had enough cornea flap. I feel that
the first md from lasik plus in tampa fl neglected my care and eye.
He never addressed an infection. I was put on large dosages of pain
killers and tranquilizers and sleeping pills for the pain. Each time
i would visit the md, he would say 2 more weeks and you will be
healed. If i would have not gone to another md, i would have lost my
eye.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037947
Laser: VISX S4
In 2007, i underwent lasik vision correction surgery. I was screened and
declared a perfect candidate for the surgery. The surgery itself
went exactly as planned with no "surgical" complications. According
to the dr, the healing process also went normal and i was declared
to have an excellent outcome due to my low refractive error.
However, in spite of this, the results of this surgery were actually
disastrous. Although my post-surgical refractive error is quite low,
the surgery induced a significant level of higher order aberrations,
including a highly abnormal level of spherical aberration and coma
due to a correction zone that is much smaller than my scotopic pupil
size. I see fine in direct sunlight and natural lighting, but have
difficulty seeing clearly under normal levels of indoor or
artificial lighting. I can not see clearly in many indoor
environments during the day, particularly on overcast days, and i
have consistently poor quality of vision indoors in the evenings due
to significant loss of contrast sensitivity. I frequently experience
halos around indoor lighting. It is also very difficult to drive at
night due to significant starbursting on all light sources, which
results in a significant loss of depth perception. I can not enjoy
many leisure activities such as watching movies. Watching television
with lights on can be quite challenging due to poor quality of the
image i see, and going out at night is difficult. None of these
vision quality issues can be reliably corrected with glasses or
contact lenses, and when dealing with eye drs, i find that my pupils
are now considered to be abnormal and i'm lumped in with individuals
who have diseased corneas. Although i did sign an informed consent
form, this form was treated as a formality and it was represented to
me that with the latest wavefront technology, the types of
complications detailed in that consent form were mostly a thing of
the past. I also expected to be notified if i was at a higher risk
for any of those complications -i. E. Due to my larger than average
pupils, etc. , but was not adequately notified of my higher than
average risk factors. I have spent a significant part of the last
year trying to cope with the emotional turmoil and anxiety that have
resulted from the loss of visual quality from an elective surgery
that was supposed to improve my quality of life. I did not need this
surgery, and based on my results, it clearly is not as safe and
reliable as it was represented to be.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1038014
Lasik laser eye surgery - sight is good, but dryness now coming on two
years has not improved.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1038017
I had lasik eye surgery approximately 5 years ago. I did not receive
20/20 results, but did experience exceptional clarity after having
very poor vision for some time. In the last 6 months, i noticed that
my vision seemed to worsen. It was not as clear as it used to be. I
could not read as far away as i used to. I am aware that the natural
deterioration still occurs due to aging of the eye, but did not
expect to experience this at a young age. I have trouble driving at
night. My eyes are exceptionally sensitive to light -specifically
during nighttime- and i find it hard to focus. Lasik summer - 2003.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1038018
Had lasik surgery. Results, eyes tire easily, difficulty focusing,
blurred vision, blinking, difficulty reading, avoid evening driving.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1038021
Lasik: developed fungal infection under corneal flap os during one of
multiple relifting and smoothing procedures as follow-up to surgery
-to remove corneal wrinkles. Referred to ophtho dept; many
photographs taken. Prolonged therapy with multiple antifungals.
Eventual resolution with residual corneal scarring -luckily out of
field of view-.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1038025
I had lasik surgery on both eyes and woke up with terrific vision. My
right eye had been -975- so this was a wonderful day for me. Within
4-6 weeks, i had to have my right eye done again, because it slipped
back to about -200. Now, 9 years later, i have eye plugs in both
eyes because they are so dry, use drops several times per day, and
have to wear glasses to see to drive or watch tv. My right eye has
slipped back again, and my left eye is blurry. I have also developed
sjorgens syndrome- so i don't know how much the dry eye is from that
or the lasik.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1038029
Had lasik surgery three years ago. Since then, i have bad vision at
night, i see halos around bright lights, and star bursts. Vision
during the day is great, but at night it is not very good. I also
have dry eyes all the time.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1038034
Lasik -- i had high myopia -roughly -10 diopters- and large pupils. I
did my research, and asked many questions about problems like halos
and blurry night vision. I was assured my chances of those problems
was low. Sure enough, i still have significant problems with halos
and night vision more than 10 years later. And the level of
correction "missed" by a significant amount -- 1. 25 on one side,
-1. 75 on the other.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1038044
Over two years ago i had lasik performed on both my eyes. The dr was
thorough in addressing possible hazards and counseled me. I was very
near-sited with a serious astigmatism and had worn glasses since 7th
grade. Probably needed them well before that. I was better than
20/20 correctable with glasses. After counseling i opted for
mono-vision, which would have allowed for book/computer reading in
one eye, and distance/driving in the other. The surgery resulted in
both eyes being far-sighted. I then underwent 2 - 3 additional
corrective surgeries. I am still not satisfied with the results. I
cannot file my nails, read most non-computer correspondence/print,
properly apply facial cosmetics (eye liner or mascara), etc. Reading
glasses do not help with these problems either. Another puzzling
complication is that i even have trouble with such mundane tasks as
putting away laundry, arranging my closet and dresser drawers,
filing personal papers, etc. My eyes tire easily. Prior to the
surgery, i could read books, magazines, personal papers (bills,
etc), watch tv, etc. All day long with no ill effect. Now i tire
within a few hours. This affects my work and earning an income.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1038045
Adverse results from lasik. Twenty months after the procedure: blurred
vision at all distances, ghost images, halos, starbursts, dry eye,
poor contrast sensitivity. Procedure in 2008. Treatment for
blepharitis in the next six months. After that, no treatment other
than continued use of restasis and intake of fish and flax oil to
encourage tear production.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1038072
I had lasik to correct near-sightedness, and although i can see well
since the surgery, i do have very diminished night vision, very dry
eyes, and sometimes have difficulty in focusing on things. This is
much more pronounced when my eyes feel dry. If i try to read for any
length of time, my eyes dry out a lot, and it's hard to focus on far
away objects after that. Before the surgery, i was able to read for
hours, and not have this problem. I do wish now, that i had not done
the surgery, but it's too late.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1038076
Following lasik surgery, i experienced gradually increasing halos and
starburst as well as a general deterioration of night vision.
Additionally, i continue to experience "floaters" in my field of
vision, particularly on the periphery of vision. Finally, my reading
vision has degraded inexplicable ( no significant family history of
such at my age). The doctors and technicians explained that halos
and starbursts might be a temporary problem but assured me that they
would stop and fade shortly after the initial procedure - this was
over four years ago. The other problems i encountered were not
mentioned to me at all. At this time, i am limited in my night
driving as a result and forced to employ strong reading glasses in
my professional life in order to maintain basic clarity when
reading. The facility i used was vision center.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1038078
I had lasik surgery to correct nearsightedness in 2004. I have since
developed halos and starbursts at night, affecting my vision and my
ability to drive. I was given prescription glasses which do not
really correct the halos and i cannot drive in the rain.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1038080
Lasik procedure was done in 2007. Ok for a couple of days, then eyesight
got progressively worse. Many follow-up treatments, later an
"enhancement" was done to one eye. Eyesight has gotten progressively
worse with that treatment also. Now they are considering doing a
third treatment in a couple more months. Thousands of dollars spent
and little improvement to vision.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1038083
In 1999, i went in to have lasik eye surgery laser center. The doctor
cut a deep flap on the first eye. He then went on to laser and
penetrated into my anterior chamber and then aborted surgery. He
never did the second eye. I went in with -7. 00 diopters in both
eyes and came out with a -22. 00 in my right eye. My doctor was
disciplined by the bme in 2006. My present doctors recommend that i
have a cornea transplant.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037585
It is still too early for me to definitively evaluate my "advanced"
-maybe it's called wavefront?- lasik, since the eye doctor tells me
that it takes several months to stabilize. I'm trying to be patient,
but i'm still waiting. I have severe myopia, and the surgery did
seem to improve my vision greatly in that regard. I can read road
signs, if the print is large enough, without glasses now, whereas
before i would not be able to recognize a person's features if their
face was 3 feet away. However, my vision is blurry, and i suspect
that is a bit of astigmatism that hopefully can still be corrected
if i am allowed to go in for a follow up procedure. The halos around
lights at night have subsided but are not totally gone. I am unable
to focus a camera perfectly through the viewfinder. I hope that i
can have a correction made, but if not i am going to have to ask to
get glasses and hope that my vision will be clearer. I did not go
into this procedure with unrealistic expectations. At best, i was
hoping that i would have incredibly clear vision, like a celebrity
in the promotional posters must have, because i know he would not
settle for "close enough. " at worst, i was hoping that at least i
could function if i lost my glasses, and this is the case. However,
i do feel that people should be very careful about what they think
will happen after lasik. So far i have not had any complications
other than dry eyes, but it is still too early to tell about that
either. Now that i talk to my friends who raved about the surgery
that they had done years ago, i find out that their vision is not
perfect either, but they don't seem too concerned about that. People
need to know that it is a complex surgery and to get things perfect
is not guaranteed. They either need to read the fine print, with
their glasses, or the doctors need to be more honest and spend more
time with the pt to make sure they understand all of the details. I
am in the midst of several follow up exams at my optometrist. He has
pronounced my vision to be 20/20, although i am telling him that my
vision is still blurry. He tells me that the eyes are still healing
on the cellular level, and that they are dry. I am waiting before i
can fully evaluate the effectiveness of the procedure, but it has
been several months and i still do not have perfect vision. I do
need reading glasses, but at the age of 50 i was expecting this. It
is my far distance vision that i am concerned about. Tlc laser eye
center, lansing, mi.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037588
Had lasik surgery and had 20/20 vision for the first year or so.
Nighttime vision has been increasingly difficult, starbursts around
lights has been constant, and overall daytime vision is now around
20/50 after 7 years -failed the eye test 4 years after surgery. Eyes
take longer to focus and adjust on objects. I have had to wear
glasses or contacts for driving, sports, and most outdoor
activities. Overall, i am not happy with the adverse effects that
have been happening since i had the surgery.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037589
Experiencing starbursts and halos when looking at light sources after
having lasik eye surgery.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037590
Lasik surgery. I've had 5 different lasik surgeries. I was not pleased
with the information given to me. Need for reading glasses. They did
not effectively warn me about the acceleration of the need for
reading glasses, due to the surgery. I did not need any type of
bifocal lenses prior to the surgery. They corrected my vision, so
that one eye was designed to read up close and one to see far. This
causes all kinds of frustrating problems. I ultimately had more
surgeries to correct this and chose to start using reading glasses
rather than have the constant strain on one eye, or the other. Need
for repeat surgeries. I was also told that, once corrected, i would
never need another surgery. I was fine for about 2 years, but then
my vision started to decline again. I had another surgery to correct
one eye a year ago, and the other eye is now over 20/50 again. I had
purchased a life-time adjustment plan on the original surgery. When
i called to get the other eye corrected again, they informed me that
they no longer support the life-time plan and i would have to pay
another $ to correct my bad eye. They have obviously figured out
that the surgery doesn't last, and it is costing them money.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037591
Had lasik on both eyes. Right eye - my dominant eye was still slightly
blurry at a distance. Wanted distance vision corrected, even if this
meant wearing reading glasses. Doctor re-treated 3 months after
initial treatment with another lasik procedure. After the second
treatment, my eye was much worse. Right eye is now at 20/100. I see
5 or 6 of everything with that eye, and cannot see anything, but a
blur at night. Doctors proclaimed the procedure a success due to the
fact that with both eyes open i could see 20/20. Suffer from dry
eyes, but i am able to treat this with otc drops.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037592
I first had lasik eye surgery on both eyes in 2003. Within a year after
the surgery, my left eye had worsened from 20/20 to where i needed
corrective glasses. I went ahead and had the surgery over again in
that eye only. Now my left eye sees very well. However, my right eye
has over the years begun to get blurry, to where i can no longer see
street signs with that eye until i am right under them, and i have
trouble reading very large power point presentations. My right eye
is very blurry and it causes headaches because my eyes have such
different vision. I have resisted going back to the eye doctor for
the fear that they will tell me i need to have yet another surgery,
or get glasses. It's gotten to where i am not comfortable driving at
night, so i am going to get glasses. Since my original surgery, i
have read that lasik shouldn't be done on eyes that are potentially
still changing. I wonder if that's what happened in my case, since i
was only 23 when i first had the surgery. Either way, i am not
totally dissatisfied with the procedure, because it is certainly
better than before, but i wouldn't say i am completely satisfied,
and i am scared of what may continue to happen to my vision in the
future
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037594
After i have lasik surgery, i now have starburst when i see lights at
night, more so in my left eye, then my right. My night vision is not
as good as it used to be. I have the ghosting effect, double images
when i am in the dark looking at something that is in the light.
From the audience looking at a stage. I have a hard time reading now
because of my left eye and the ghosting effect. Things in my left
eye are bigger and blurrier than in my right eye. All of these side
effects are there even though i technically have 20/20 vision now. I
would have preferred to wear contacts for the rest of my life and be
able to read than have 20/20 vison and not able to read.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037599
Lasik surgery to both eyes. Procedure was to create "mono-vison" with
left eye for distance vision, and right eye for near vision. Initial
surgery failed as right eye healed with a focal distance of approx 8
inches instead of the desired 24 inches. After three months for the
initial surgery to heal, a second procedure was performed to correct
the right eye. This procedure also failed, as the right eye now had
a focal distance, approx 30 inches. The surgery center suggested
solution was to alter the left eye, which had headed properly
following the first procedure. I declined, not wanting to risk my
vision any further. The initial assessment was performed by a
technician and an optometrist. I did not see the surgeon until just
minutes before the procedure. To this day i require eye drops
several times a day - a possibility that was not impressed upon me
prior to the surgery. After 21 months, i gave up squinting in order
to read and returned to glasses. I now wear tri-focals. I believe
the decline of my near vision, which was fine before the surgery,
was hastened by the surgery. I would not recommend this surgery to
anyone.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037601
Approximately, ten years ago i had lasik surgery. After the surgery, i
experienced halos and starbursts around lights at night and double
vision at night such that headlights and street lights were double.
This problem has improved over the years, but, i still have problems
at night with lights - milder halos and starbursts. If i had a
choice now, i would not have lasik surgery.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037603
Had lasik with customvue on both eyes. Vision is now good, but sometimes
unstable esp towards latter part of the day. On-going problems
include: dry eye problems and floaters which occurred as a result of
the procedure. The dry eye problem has been mostly taken care of by
daily eye drops and punctal plugs.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037638
I had lasik surgery - ladarvision 4000, with intralase at eye institute.
Since then, i have had starburts at night, severe and painful dry
eye, and increased floaters.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037644
Pt had lasik surgery at facility by dr. In 1999, on his left eye.
Subsequent to, and as a direct result, of this surgery the pt
acquired chronic impaired night vision - starburst, glare, and
halos. Additionally, he has dramatically reduced contrast
sensitivity. This was confirmed on a contrast sensitivity test in
2000, where his left eye scored 50% but his right eye - unoperated -
100%. Because of the devastating negative outcome the patient
decided against the planned lasik surgery on the right eye. The
disparity in the visual acuity of his eyes resulted in a secondary
condition of anisometropia and he is now dependent upon a contact
lens in his unaltered right eye as his only means of balanced,
corrected vision. As to a cause of the negative outcome it became
clear to the patient after second and third medical opinions that
his left pupil size was large and made him a poor candidate for
lasik - 6mm ablation zone and patient has 8mm to 9mm pupils on low
light. Facility incorrectly assessed his pupil size at 6mm in low
light. The patient recalls that his screening by a technician at
facility was done only using a card with varying sizes of black
circles. He now has learned this to be the most primitive of
techniques in assessing pupil size and there is also no standard for
pupil measurement - whether devices or techniques - in the u. S. He
is also dismayed that dr. Did not independently verify his pupil
size at any point prior to surgery. There is apparently no surgical
recourse for this outcome of poor night vision, anisometropia and
loss of contrast sensitivity, none of which were disclosed in his
consent form for the off label use of the summit laser for lasik. In
1999. Lasik surgery performed by dr. At facility, affiliated with
another facility-. Dates of use: one day in 1999. Diagnosis or
reason for use: correct lasik refractive eye surgery.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037656
I had lasik surgery in late 2003 by a dr. It was traditional lasik using
a b & l technolas laser. The outcome was not as i expected. I share
the blame as i signed a document that i fully understood the risks
of the surgery. I only did so after being assured, by the physician
himself, that i was an excellent candidate and would love the
results and that the possibility of complications were extremely
small. I was never told about dry eyes, complications of night
vision, possibility of ectasia, etc. Needless to say, i feel as
though, i was swindled by a very good salesman. I was a -3 to begin
with and regressed to a -1 following the surgery. I still struggle
with dry eyes today, over three years following the surgery. I have
difficulty driving at night because of the halo effect of oncoming
traffic lights. I would urge the fda, to put some type of procedure
in place that would let the general public know that some
individuals wished they never had the surgery. Perhaps have them
watch a mandatory dvd of people who have had bad experiences. I
think this should be part of the sales pitch that the doctors make
when trying to get patients to come to their establishment for the
procedure. It's too easy to have the procedure, especially when
something as vital as your eye sight is on the line.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037657
I had custom intralase lasik in 2007. My vision in my left eye was 20/40
after surgery. I had an enhancement done in seven months later on my
left eye. Several weeks after enhancement, i noticed floaters in
both eyes but especially in my left eye. These have not improved in
the 6 months or so after my enhancement. These floaters consume most
of my waking thoughts. I have researched for hours to find out there
is nothing that can be done about them. They have caused me enormous
stress and depression. I have a hard time with the thought that i
will have to live with these forever. When i had the surgery, there
was never any mention of floaters in the papers that i signed. I
realize i took a risk having surgery, but is it possible that a
study could be done to determine if floaters are indeed caused by
lasik? there are so many people that have floaters that are
struggling to cope with this garbage in their eyes. I know it is not
a life threatening condition but i know that quality of life is
definitely diminished. Please take this seriously. I would go back
to my glasses days in a heartbeat ! !.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037658
After "all-laser" lasik with wavefront, i am experiencing
vertically-stacked double images in both eyes due to astigmatism
introduced by the surgery, see halos and flares at night, and i have
a corrected vision level of 20/40.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037659
In 2003, i underwent bilateral lasik using the visx customvue platform
following the screening by and recommendation of a dr of eye center.
I was informed that i was an excellent candidate for the procedure
and inquiries as to whether pupil size and/or size of correction
were potential adverse considerations in the determination of my
candidacy, such concerns were very cursorily and flippantly
dismissed and the customvue technology was purported to eliminate
the adverse consequences experienced by some, prior lasik procedures
- with advertisements showing pictures of rep visual outcomes with
and without customvue technology. The result of the procedure was
the immediate inducement of visual smearing - far worse than
anything ever seen in even the poor outcome representations that
customvue was to render obsolete - upon expansion of pupils in
indoor, dim lighting and nighttime settings, a directional smearing
and loss of contrast sensitivity due to the cumulative effects of
such smearing. In inquiries immediately following the surgery, dr
alleged that the visual smearing - very precisely and accurately
described by me - could potentially be the result of brain / optic
nerve issues that would necessitate visiting a neuroophthalmologist
that could potentially be extremely serious - and, of course, of no
relation to lasik. I visited a neuroophthalmologist who concluded
the results to be caused by lasik and that i had extremely dry-eyes.
Dr would later cite psychological problems and the need to seek
therapy-. The cause of the induced problems were very clear and
obvious to those with even a casual understanding of the subject -
and even the tiniest degree of honesty, integrity or compassion for
human beings-: the ablations were systematically decentered
superiorally which, when coupled with inadequacy of optic zone for
size of pupils (note: pupils were noted at "16. 0mm" with lights off
by pre-qualifying examiner - dr of another place- despite being
extremely large even to the casual observer - registering at 8. 0mm
by physicians in subsequent visitations; as such,
qualifying/referring practitioner likely set the pupil size equal to
the size of the treatment zone so as to conclude one to be a good
candidate, not because it is actually the size of my pupils and
amount of tissue removed, accounted for all of the visual problems
experienced. This is very clearly evidenced by all topographies;
this was not the product a biomechanical instability of the flap
manifesting itself as an undesirable healing pattern but by an
incorrect alignment as achieved by the laser platform and the
practicing physician, which is supported by artemis scans and the
immediacy of symptomatic descriptions. The flagrant lies following
the procedure caused tremendous mental/psychological distress - i am
not a complete idiot, so i had a sense that i was being lied to by
first dr and assorted referring physicians concerning the cause and
prognoses of the devastating and life-altering results - due to the
fact that i soon realized i could not obtain the truth concerning my
current condition from anyone in the industry - i visited many
throughout the country - due to their interests in protecting their
colleagues and their profession. What i encountered during my
efforts to work with the medical community - the willingness to do
and perpetuate harm at any cost for - albeit tremendous - personal
gain; greed manifested by a desire to perpetuate a practice at any cost and any level of dishonesty and obfuscation in the midst of
those literally crying for help or at least acknowledgement of
problems induced if help was not possible - beyond any description -
was something i will never forget. I obtained confirmation of the
truth of what was done to me only upon traveling overseas - to
london, england - a tremendously painful and difficult trip given
the dry-eye and visual disruptions - apparently severing the code of
silence on my travel across the pond. Perhaps even more importantly,
the lies perpetuated by the lasik community during my inquiries
immediately following the surgery very likely caused a further
life-long devastating condition: dry-eye. First dr prescribed
alphagan p approx 10 days post-op - without the disclosure of its
potentially devastating dry-eye effects if applied to recently
ablated eyes during a crucial time/window when corneal nerve
regeneration is of utmost importance - due to the devastating visual
effects - and election not to disclose the reason for the
directional smearing and consequent ineffectiveness and
inadvisability of pupil-constricting medication as a post-op,
long-term solution given the cause-; he then prescribed
c-pilocarpine due to lack of efficacy. Dr holzman then prescribed -
within approx 2 months of the surgery - corneal gas permeable
lenses; the practitioner to whom he referred me had no experience
fitting such lenses in post-lasik cases. The pain of lens wear was
truly excruciating. All of these courses of actions prescribed
likely retarded corneal nerve regeneration during the time period in
which such regeneration is crucial, resulting in the -extreme,
irreversible- symptomatic onset of dry-eye pain, which progressively
worsened to a constant and debilitating state.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037660
I had lasik surgery in 1998 and following, have post lasik ectasia in
both eyes. My vision has progressed to the point where my left eye
is legally blind, and i function using my right eye, which gives me
20/60 vision but with severe astigmatism, so i have constant
disabling headaches. I also wear an eye patch on my left eye because
my brain cannot process the images produced by the eyes at the same
time - anisometropia - without getting even more severe, intolerable
headaches. Because of the constant headaches and low vision, i
cannot work or attend school and i do not qualify for disability.
The surgery - performed, using a visx laser - has absolutely ruined
my life. I am not a good candidate for a cornea transplant because i
have extremely dry eye, also exacerbated by lasik surgery. This
surgery has destroyed my life. Please contact me if you want further
info.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037661
I received bilateral lasik surgery with the visx inc. Star excimer laser
system and have had significant ongoing vision problems post-op. I
had no surgical complications (flap problems, infection, etc).
However, i have significant higher - order abberations, resulting in
poor vision acuity and quality and double vision (daytime and
night), and glare - especially at night. My best corrected vision
with lens and/or spectacles is much poorer compared to pre-surgery.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037662
Surgeon cut a short flap during lasik procedure and did not abort
procedure. Eye was lasered in only one half of intended area, and
the underside of the flap was also lasered, resulting in a severe
permanent scar in the field of vision.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037663
I need contacts for both eyes, but i had lasik on my right eye only due
to my flexible spending account situation. I now have a harder time
seeing out of that eye at night because of the starbursting that was
supposed to go away after i stopped using the medicated eyedrops.
The doctor told me it would be a day or two after i stopped using
the eyedrops that my starbursting would go away. It has now been
three weeks since surgery, and there is no improvement with the
starbursting. My left eye still sees normally at night when i wear
my contact. My right eye vision has been corrected, but i notice
smaller starbursts during the day and big starbursts at night. I was
planning to have the left eye done as well, but i don't want to do
it until i know my right eye night vision improves. I might be part
of the 5% who experience permanent starbursting after the surgery
since the effect is taking longer to go away than the doctor
expected. I have a true before and after comparison and i am not yet
satisfied with the results.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037785
I have had three lasik surgeries to correct my vision. At no time did i
ever achieve the "20/20" ideal. My eyes keep regressing. After the
first surgery, they poo-poo'd me and told me to use more eye drops.
I thought this was absurd as i was not going to use eye drops every
few mins just to see, and my eyes did not feel dry. Since the first,
i have had bilateral lasik and a third in just one eye. Within one
year of the final surgery, i was back in glasses to see. I was now
in bifocals, which was not needed before. I heard the article on npr
radio this morning. If this is the info you need, i will be happy to
research my records for more detail.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037786
Received lasik eye surgery on my right eye. Prior to my appointment i
had many scans from the tlc ctr on my right eye. I had all the
required pre-op appointments. The day of my surgery, the doctor put
the ring around my eye. The device was off ctr and had to be
adjusted and put back on. My eye ball swelled and i had a large red
ring where the device was. The lasik was performed. Outcome was
good. Two months later, i awoke to great pain in my right eye. Later
that morning, i noticed that i was missing vision from the ctr of my
eye up. I was like someone pulled a shade over half my eye. I went
to the eye doctor for my follow up visit, and i mentioned this new
development. My retina detached. I had to see a specialist for a
scleral buckle. This reattached my retina. However, i no longer have
20/20 vision in my right eye. I was told they can reperform the
lasik to recorrect my vision. After all that, i went through i do
not think i will have it redone. I have since gone into a deep
depression and now i am being treated for that. I still have to see
the retinal specialist for check up. I have very poor night vision
in my right eye. In the paper work, i signed for the surgery for
lasik procedure it did say that there was a possibility of detached
retina, however, i did not understand what that meant.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037787
I don't remember the exact date, but it was sometime in summer of 2000.
I had lasik surgery and i'm semi-unhappy. Vision is not as good now
as i had hoped it would remain, even though it was about 20/15 for
some time after the surgery. Severe dry eyes and halo effect,
uncomfortable at times with night vision/driving. Surgical results
still better than contacts were for me, but overall wish i had stuck
with glasses, i think. I continue to use restasis eye drops for dry
eyes and experience much discomfort most mornings wear glasses to
bring vision back up to 20/20. Must have 20/20 for my job.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037788
Re: lasik surgery - adverse outcome. I understand the fda is
investigating lasik surgery and is soliciting feedback from
consumers who have had poor outcomes. I am reporting an adverse
result. Here's my story: had the procedure done in 1999. The
procedure was a failure from day one. I never fully corrected my
vision and has deteriorated ever since. Initially after the
procedure, i got by without glasses or contacts, but it was a real
struggle to see. I then had to very regrettably go back to contacts,
but had to wear soft "toric" lenses which i had never had to wear
before. I had some astigmatism pre-op but, the lasik made it even
worse. In the past two yrs, i have become fully contact lens
intolerant. They do not correct my vision, they actually horribly
distort it. I have tried many different types, including "hybrid"
lenses for post surgical patients. I must now wear glasses 100% to
see. My corneas are severely distorted and i have a bulging thin
spot at the bottom which precludes any further procedures. I am not
correctable to 20/20 with glasses, so bottom line, lasik has been an
absolute disaster for me. I have gone for multiple opinions and have
been diagnosed as having lasik ectasia, keratoconus, pellucid
marginal degeneration, pmd, and "we don't know why it didn't work. "
i was told that i should never have had the surgery looking at my
pre-op topographies today, but i had gone for 3 evals before doing
the surgery and no one had expressed any concerns or that i wasn't a
"candidate. " so on top of having an extremely poor outcome, my
other complaints are dry eye, and lots of junk in my vision,
floaters and flashes. It has also been pretty devastating
emotionally to hear all the glowing lasik stories, while i now have
fewer corrective options than i did before the surgery, my bcva
isn't event 20/20. There are also the time and personal expense
issues of flying to see specialists, going to multiple appointments
and the absurdly expensive treatments, intacs, c3r and special
lenses that don't even work.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037789
Underwent lasik procedure; unfortunately have redeveloped vision deficit
and halo with difficulty with night vision especially while driving;
now using contact lenses again but with less myopia than before.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037790
I am glad to know fda is looking at lasik side effects. I feel i gained
more from the surgery than i lost and i never filed a complaint with
my doctor. I thought i was informed of all the risks, but i think
things were not known at the time. While i had 20/20 vision for
several years and the initial results were very dramatic, my
eyesight has worsened over time. I began wearing slightly corrective
glasses in 2002. Now i wear glasses most of the time. It isn't
absolutely necessary in the daytime, but since my vision is not
perfect, so it helps me, esp. With my weaker eye. It went back to
being the weaker eye. More seriously is the fact that my night
vision is seriously impaired. I cannot drive without my glasses at
night. I do fine in the city where there is a lot of light at night.
And, rarely found myself driving in darker places. But, i discovered
a couple of years ago that i cannot drive in areas where it is
darker and single lights serve the purpose of lighting. Single
highway lamps or other cars headlights completely disperse and
obstruct my vision. The light bursts out in lines in many
directions. Seriously, i will not drive at night under those
circumstances.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037796
Following lasik surgery, my eyes no longer produce natural tears. To
control the extreme dryness, use eyedrops throughout the day. I also
need to wake up throughout the night to use the eyedrops; typically
eight times per night. I use one large bottle of eyedrops per week.
In the two years following the surgery, i also have experienced
frequent headaches and frequent eye infections.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037797
I had lasik surgery and was promised 20/20 vision with no need for
glasses. Two yrs later, i still experience dry eyes, need for nearly
constant wear of closeup glasses for 1st 10 feet, and fuzzy night
vision. I am a physician and waited to have the surgery and only let
myself do it because, it was explained to me that all the kinks were
worked out of the procedure. I am able to see distance without
glasses, but if i was clearly explained the downsides which i
experience i would have waited more yrs for further improvement in
the procedure. Unfortunately, medicine in this country has become
big, maybe biggest, business and doctors, medical industry,
hospitals are not under any real self, government, or fda ethical,
moral quality control, in my field of orthopedics millions of
unnecessary mris, xrays, procedure, surgeries and labelin
