FDA Panel Urges Stronger Warnings for LASIK Surgery

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On Friday, the FDA advisers recommended that the agency make clearer the warnings regarding LASIK surgery. The recommendations include: adding photographs to illustrate what people suffering certain side effects actually see, such as the glare that can make oncoming headlights a "starburst" of light; clarifying how often patients suffer certain side effects, such as dry eye; and making clearer the conditions that should disqualify someone from LASIK, such as large pupils or severe nearsightedness, the AP reported.

"The FDA has called this a quality-of-life issue, because patients are complaining that their vision isn't sharp, they have poor night vision, some have glare or halos, some complain that their eyes are dry," said Dr. Robert Cykiert, associate professor of ophthalmology at New York University Langone Medical Center.

Some of those disgruntled patients were on hand for Friday's FDA hearing.

"Too many Americans have been harmed by this procedure, and it's about time this message was heard," said David Shell of Washington, D.C., who had the surgery in 1998 and said he has "not experienced a moment of crisp, good quality vision since," the AP reported.

Colin Dorrian was a law school student from suburban Philadelphia when he was told he wasn't a good candidate for LASIK, but got the surgery anyway. His father, Gerald, detailed on Friday the six years of eye pain and blurred vision experienced by his son, before reading his child's suicide note: "I can't and won't continue facing this horror," the news service reported.

Matt Kotsovolos worked for the Duke Eye Center when he had a more sophisticated LASIK procedure in 2006, and said his doctors classified him as a success because he now has 20-20 vision -- something Kotsovolos called a deceptive industry practice, according to the AP.

"For the last two years, I have suffered debilitating and unremitting eye pain," Kotsovolos said. "Patients do not want to continue to exist as helpless victims with no voice."

LASIK (laser-assisted in situ keratomileusis) surgery involves cutting a small flap in the eye's cornea using a laser. With the flap held out of the way, the surgeon can then reshape the corneal tissue with another laser. The procedure can be used for nearsightedness (as in Tiger Woods' case), farsightedness and, in some cases, astigmatism.