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FDA Panel Urges Stronger Warnings for LASIK Surgery
Date:4/25/2008

DA panel will also advise the full agency about how to conduct a $1.2 million study that the agency is planning with the National Eye Institute and the American Society of Cataract and Refractive Surgery to determine patients' quality of life after LASIK, the Washington Post reported.

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 L
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