It warns that after the procedure, patients could be left with double vision, dry eyes, difficulty driving at night, and in some cases, persistent eye pain.
More than half a million Americans undergo LASIK surgery every year, according to the report.
The FDA advisory is not final, and more than 600 individuals and professional groups have weighed in on the draft since July. The FDA will review the input before publishing the final documents.
Surgeon and medical device representatives are not happy with the report, with many accusing the FDA of publishing one-sided information and reports.
“All we’re asking for is balance,” Vance Thompson, MD, incoming vice president of the American Society of Cataract and Refractive Surgery, told the Times. “This document mainly emphasizes the dangers and complications of LASIK, with no mention of the advantages, and the tone is negative enough that it will scare patients.”
Dr. Thompson noted that LASIK is the safest procedure done on the eye, and that 90 percent of all patients express satisfaction after the surgery.
The 29-page guidance has been in the works for 10 years, and most of it is about the risks, according to the report.
The FDA is proposing a “decision checklist” that would highlight risks; however, they would not require that all physicians distribute it.
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