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Experts Advise New Warnings for LASIK

Patients Tell FDA Panel About Serious Side Effects From Corrective Eye Surgery

Debate Over LASIK continued...

Some advocacy groups have said the FDA's national study lacked independence because it was being run in part by ASCRS, the group representing doctors performing LASIK and other procedures.

"The FDA will objectively evaluate the information collected," said Eva Rorer, MD, the chief of FDA's ophthalmic division.

Still, some experts said Friday they had difficulty knowing what new warnings to recommend for LASIK patients.

"I think there are many aspects of risk related to LASIK that we have yet to find out," said David C. Musch, MD, a professor of ophthalmology at the University of Michigan and a member of the advisory panel.

Peter McDonnell, MD, professor of ophthalmology at Johns Hopkins University School of Medicine, says the surgery has been studied extensively. According to a news release about the FDA meeting by the American Academy of Ophthalmology, McDonnell says, "LASIK is the most studied elective procedure. ...I believe it is safe to say that no elective ophthalmic surgical procedure has been as fully studied as has this procedure. But, as with any surgical procedure, there are complications that may occur after LASIK. Fortunately these are uncommon. No matter how uncommon, however, when complications occur they can be quite distressing to both patients and surgeons."


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