FDA recommends changes for eye laser patient labeling during public hearing

| Apr 29, 2008 | Comments 0

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.

Filed Under: LASIK • News • Safety

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About the Author: Mr. Dave Allamby FRCS FRCOphth is a leading London-based laser eye surgeon. You may have seen him on the This Morning TV show with Phillip Schofield and Fern Britton or read one of several articles in the national press, recently for treating Denise Van Outen, rock giant Rick Wakeman and broadcaster Paul Ross. David is Medical Director at Focus Laser Vision, known as a world-leading clinic in the treatment of presbyopia, or age related loss of close vision. Focus Laser Vision is also London's only clinic to offer next-generation Z-LASIK laser eye treatment for short sight, long sight or astigmatism.

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