FDA recommends changes for eye laser patient labeling during public hearing
Leading ophthalmologists plus LASIK patients at the Food and Drug Administration (FDA) Ophthalmic Devices Advisory Panel (ODP) presented two conflicting perspectives on the LASIK laser eye surgery procedure last week.
After hearing data and moving stories from both sides, the action taken was a number of recommendations on how to improve patient labeling of eye lasers and the FDA’s LASIK website page; how the FDA should recognize the American National Standards Institute’s (ANSI) standard for laser systems for corneal reshaping (Z80.11); and possible amendments for a list of LASIK-related adverse events for self-monitoring of the procedure.
After hearing stories from dissatisfied LASIK patients, Jayne S. Weiss, M.D., professor & Director of Refractive Surgery and Ophthalmic Pathology, Kresge Eye Institute, Wayne State University, Detroit plus ODP acting chairwoman, noted that while the stories are important the panel’s goal is to see the big picture. “Individual stories are compelling, but we need to put it into context,” said Dr. Weiss.
