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More Warnings for Lasik Surgery, FDA Panel Says

Apr 28, 2008 | Parker Waichman Alonso LLP

At a meeting of the U.S. Food and Drug Administration's (FDA) Ophthalmic Devices Panel Friday where post-LASIK quality-of-life issues were discussed, it was recommended the FDA ensure clearer warnings outlining the risks of LASIK, according to the Associated Press.  LASIK—laser-assisted in situ keratomileusis—surgery involves using a laser to cut a small flap in the eye's cornea to allow for reshaping of the corneal tissue with another laser to correct nearsightedness, farsightedness and, sometimes, astigmatism.  Lasik was approved a decade ago and an estimated six million Americans have undergone Lasik surgery.  The surgery permanently reshapes the cornea, there are no guarantees of 20/20 vision, and the long-term safety of Lasik remains unknown.

The FDA has received 140 letters of complaints.  "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.  FDA advisers recommended the agency clarify warnings regarding LASIK, including:  Photographs to clearly show what people with side effects see, such as glares and light bursts; information indicating how often patients suffer side effects, such as dry eye; and clear information outlining the conditions under which someone should be disqualified from LASIK, such as large pupils or severe nearsightedness.

According to the Associated Press, David Shell of Washington, D.C., had LASIK in 1998 and said he has "not experienced a moment of crisp, good quality vision since.   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 has 20-20 vision, but Kotsovolos said, "For the last two years, I have suffered debilitating and unremitting eye pain.”

Colin Dorrian, 28, a patent lawyer and aspiring medical student from Philadelphia committed suicide last summer, six years after Lasik surgery left him with visual distortions.  Colin was told he wasn't a good candidate for LASIK, but got the surgery at a Lasik center in Canada that has since closed.  "If I cannot get my eyes fixed, I'm going to kill myself….  I can't and won't continue facing this horror," he wrote in a his suicide note, adding, "I have other problems like most people do.  But this is something else.  As soon as my eyes went bad, I fell into a deeper depression than I had ever experienced, and I never really came out of it."  On Friday, Colin’s father, Gerald, detailed the six years of eye pain and blurred vision experienced by his son.

Dr. Norman Saffra, director of ophthalmology at Maimonides Medical Center in New York City, says that LASIK is not for everyone, especially those with a misshapen or excessively thin cornea, who have early cataract formation or big pupils, who have dry eyes, or underlying conditions such as lupus or rheumatoid arthritis.   Side effects can include glare and halos around lights at night and some patients have had corneal transplants, Starr said.