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LASIK draws FDA attention, warnings

October 15, 2009 |  4:47 pm

Three federal agencies -- the Food and Drug Administration, the Defense Department and the National Eye Institute -- announced Thursday that they are launching a three-year effort to gauge how many, and which, patients undergoing the vision correction procedure called LASIK suffer troubling symptoms following the surgery.

At the same time, the FDA issued letters reminding 17 walk-in surgical centers performing LASIK surgery of their obligation to report poor outcomes and patients' surgery-related medical complaints to the agency. The letters were issued after the FDA conducted a spate of inspections of LASIK facilities and found many had no system for collecting and transmitting to the FDA data on patients' reports of post-surgical "adverse events." More inspections are to come, said the FDA.

It's been almost two decades since the "Laser-Assisted In Situ Keratomileusis" -- or LASIK -- procedure was first used in the United States, and somewhere between 1.1 million and 1.4 million patients a year now undergo the surgery to correct vision defects. Aggressive marketing has made LASIK a $2-billion industry -- and one which has come under criticism for overselling the surgery's benefits and underplaying its risks. In May, the FDA circulated a letter to eye care providers calling attention to "deceptive or misleading health care advertising claims" and outlining the limits of allowable claims that may be made for LASIK.

But while LASIK has many ardent admirers among the more than 12 million in the U.S. who have had it, between 2% and 5% of patients getting the surgery -- as many as 75,000 per year -- are thought to have lasting post-operative problems that range from painful dry-eye to poorer vision, halos, glare and even blindness. The FDA calls these "quality of life" problems following the laser surgery, and has acknowledged that it has recorded no more than a small fraction of such problems during the LASIK industry's period of explosive growth. (In the 10 years leading up to an early 2008 hearing on LASIK, the agency said it had received only 140 reports of post-LASIK eye problems.)

In the first phase of the FDA-led effort to measure LASIK's effects, the agency is drafting a web-based survey of patients who have undergone the procedure. In its second phase, the Defense Department will gauge how many active-duty military patients suffered post-surgical eye problems, and whether certain populations of patients fared worse. Phase 3, which will end in 2012, is to study a general patient population across the country to determine how many, and who, suffer problems from the surgery.

Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, says the study likely will identify which patients are at higher risk of poor outcomes and "could lead to a reduction" in those whose eye problems are made worse by the procedure.

-- Melissa Healy 

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Comments (21)

I got LASIK done on my eye last Christmas. I can see without problems. I have dry eye every morning and on long days. But other than that I am happy with my results. I can see without glass.

Big time doc in San Francisco did mine. Glasses still help me much more than the lasik. He never, ever called to follow up. Did surgery, then done. Forever.
No thanks. Get halos...glowing. Never worked well.

I have known people to have this surgery, one in America and one in Korea. Both of them have turned out fine, except the one who had it done in Korea had a bit of bleeding, but that was said as normal. Also, the one from Korea spent thousands less and got a week long hospital stay, whereas the one from America spent more and was sent home right after and had to leave work for a week per eye. Not doubting the accuracy of this article, but these are two subjects out of a massive amount of people.

However, the same issues apply to those going under any surgery, especially the gastric bypass surgery of which I have heard MANY more complaints than the LASIK.

I do regret having done lasik, I have all sorts of problems ever since, from very dry eye where I get headaches from it, to halos and glares and blare vision.
I have done the lasik about a year and half ago, and paid $5000.00 I wish I have had done it.

Why did this take twenty years to look into? Whenever you hear aggressive ads for medical tests, procedures or drugs, you can bet that the advertisers are less than idealistic in their offerings. And the high profit margins guaruntee that there will be misrepresentation and half truths.

It's a problem to the people who were left blinded by this operation.
I wear reading and driving glasses and thought about having this done.
But my personal doctor warned me of the risks and said it was better to wear glasses.
I followed his advice due to the fear I might need a seeing eye dog for the rest of my life.
I still own a dog but that is for my enjoyment and exercise.

A friend of mine got LASIC from one of those low-cost doctors in San Francisco. She wound up getting the wrong procedure and was effectively blind for eight months, until she got her eyes re-LASIC-ed by a doctor who knew what he was doing. The lack of regulation is a real problem, and the presence of make-believe eye doctors is a real danger.

Initially I had cataract surgery in my right eye and was left almost blind in that eye for nearly 5 months. Partner of the surgeon who performed the operation affirmed that I was implanted with the WRONG lens. The surgeon who did the operation went on vacation for two weeks and neither his partner nor any other ophthalmic surgeon would offer to correct the mistake. I was told to wait for the original doctor to correct the mistake. Upon his return he refused to do anything until the eye had sufficiently healed. 2 months down the road and finally he offered to do the lasik procedure to correct the error. I was assured the lasik procedure would correct my astigmatism and renew my vision. LOL. 3 months after the procedure I was still looking through a blur. I now wear glasses and my eyelid on that eye is swollen and the eye bloodshot. Been putting in drops and have changed prescriptions 3 times ( stronger each consecutive change ) over the last 2 years.

I now have 20/40 with corrective glasses in the eye that was operated on. I had 20/30 prior to the operation. Would not recommend anyone ever have this procedure unless you've exhausted all other avenues of recourse. When you lose your vision you've lost a lot.

I had Lasik done 5 Years ago and my eyesight is 20/15. Am very happy with the results. Dry Eye was an inconvenience for about the first month but Dr. recommended tear drops helped and now there is no dry eye. I believe that my doctor was educated by one of the founders. I had follow up appointments for the first (4) months. My advice is to do your homework. There are risks; however generally the procedure is believed to be safe and it has worked wonderfully for me.

BC, Ashaway, RI

I had LASIK 9 years ago with fabulous results. I know many people who had this surgery and the only one who had less than desirable results was the one person I know who went to a place that does LASIK very cheaply. I don't know why anyone would even consider surgery of any type at a bargain basement type place, but you get what you pay for.
I'm glad this is being investigated, but I would anticipate the highest number of bad results are from the cheapest providers.
Oh, and to the person who said it takes a week to recover - clearly you're mistaking LASIK for something else entirely. I drove the morning after LASIK, and never had a moment of pain or even discomfort.

Everyone here who has posted about their LASIK experiences should go to the FDA site and fill out their survey! Its important to find out who is at the most risk, why they might be at risk, and the actual odds of complications. Without knowing exactly how many people have had LASIK and what their after effects have been, there's no way to gauge how safe of effective it actually is.. Please, fill out the survey, and if you know anyone who has had the surgery, ask them to fill it out, too!
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/SurgeryandLifeSupport/LASIK/default.htm

My sister had the surgery and has minor halo issues but is fairly pleased with the results. My vision is a bit worse than hers was before the surgery, but I am not willing to risk what I have -- this is for keeps.

I had LASIK 2 years ago. My doctor under-corrected both eyes because my corneas were thin and I can still see 20/10 in both eyes. No dryness, no halos, no glares. You can get LASIK for less than $500 per eye. I spent $5,000 on the surgery, researching a number of doctors, and even viewing a surgery before choosing my doctor. Had I chosen the doctor according to price point rather than skill, record, and educational background, I wonder if the issue with my corneas would have even been detected or mentioned to me. If you have a good doctor I think LASIK is very safe. Just DO YOUR HOMEWORK and remember you get what you pay for!!

My brothers and I had LASIK done almost 20 years ago and have 20/20 or better with no problems. It has been very good for me and my work having to spend hours every week looking through microscopes. The only problem was breaking the habit of waking up in the morning and reaching for my eye glasses.

How is 2-5% of 12 million equal to "up to 75,000".

More like 240,000-600,000 with "lasting post-op problems"

Wow, that's a lot of people with messed up vision.

SO glad I had PRK surgery instead of LASIK!
No cutting my eyes!
I was lucky enough to have it done while I was in the Navy.(Bethesda)
The only problem I had was with the dry eye for about a year. You just rub the upper & lower lids after you've beenin the shower a bit to make sure the ducts don't get blocked.
I was 20/40 & 20/140 - now I'm 20/15 in both! It's been 6yrs! No problems, except I think I'm starting to need reading glasses! ugh!

I had an excellent experience and outcome with the LASIK performed on both my eyes about 10 yrs ago with Dr. Ronald Smith located in Beverly Hills. My astigmatism in both eyes had been very bad -- I would not have been able to recognize a friend standing across the street without my glasses or contact lenses prior to the procedure. The day after the procedure, I opened my eyes and was absolutely astonished to see with unaided 20/20 vision. It was the best $3,000 I ever spent in my life. As others have commented, it was also important to me to find a highly qualified expert to perform this procedure, and Dr. Smith came highly recommended by several physicians. I understand that Dr. Smith has since published a textbook on LASIK and teaches at UCLA. Although a friend I referred to Dr. Smith obtained less favorable results than mine, his vision was sufficiently improved that he did not need to wear glasses or contact lenses afterward.

I have entertained going for a consult for the new 'hi-def' Lasik surgery myself. Over the last ten years I have watched with amazement the advances in the industry and the practitioner. My last opth appt. a year ago I asked the MD whether I was a candidate and he insisted 'nowhere near what you would want to achieve', in other words the benfits would be miniscule and the risks would be great.

With computer technology enhancement procedures now, the accuracy would be considered far superior as to yesteryear. But if the FDA and other warrant an investigation, than it must be worthwhile because they don't usually get involved unless there are concerns on their part. Thank you for the heads up article.

Also, don't believe everything lay people tell you. Twenty years ago (i.e. 1989) LASIK did not exist.

Why don't they do a similar study with cataract surgery? I've known people who had poor vision and other complications following the procedure.

nice info thanks for sharing. i have found free lasik evaluation from eye surgery sacramento and little study on best candidate for lasik eye surgery must be over 18 year check link and please guide me. i will be thankful to you..
http://bit.ly/8P3j1e



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