WASHINGTON — Lost in the hoopla of ads promising that laser vision surgery lets you toss your glasses is a stark reality: Not everyone’s a good candidate, and an unlucky few do suffer life-changing side effects — lost vision, dry eye, night-vision problems.
A decade after Lasik hit the market, unhappy patients will air their grievances before the Food and Drug Administration today as the government begins a major effort to see whether warnings about the risks are strong enough.
How big are those risks? The FDA thinks about 5 percent of patients are dissatisfied but can’t provide more specifics — and is pairing with eye surgeons for a major study expected to enroll hundreds of Lasik patients to try to better understand who has bad outcomes and exactly what their complaints are.
“Clearly there is a group who are not satisfied and do not get the kind of results they expect,” FDA medical device chief Dr. Daniel Schultz said Thursday.
About 7.6 million Americans have undergone some form of laser vision correction, including the $2,000-per-eye Lasik. Lasik is quick and, if no problems occur, painless: Doctors cut a flap in the cornea, aim a laser underneath it and zap to reshape the cornea for sharper sight.
The vast majority, 95 percent, of patients see more clearly after Lasik and are happy they had it, said Dr. Kerry Solomon of the Medical University of South Carolina, who led a review of Lasik’s safety for the American Society of Cataract and Refractive Surgery.
But one in four patients who seeks Lasik is told they’re not a good candidate, he said. And there is little information about just how badly the 5 percent who get it but are dissatisfied actually fare.
