FDA Seeks Input on Post-LASIK Experiences

The Academy is presenting on LASIK at a briefing tomorrow of the FDA’s Ophthalmic Devices Panel. The meeting provides an opportunity for the FDA to hear from the public and experts about LASIK satisfaction issues; several unhappy patients are expected to testify.
The Academy and The International Society of Refractive Surgery will be represented by Steven Schallhorn, MD, former director of cornea service and refractive surgery at the Naval Medical Center San Diego and the refractive surgery program manager for the U.S. Navy, and Peter McDonnell, MD, director and William Holland Wilmer professor of ophthalmology at the Wilmer Ophthalmological Institute. While multiple studies have documented that LASIK is safe and effective with an excellent satisfaction rate and has benefited millions of patients, regulators are interested in finding out more about quality-of-life issues following LASIK surgery. To that end, the Academy is co-funding and supporting a new LASIK study with the FDA, NEI and the American Society of Cataract and Refractive Surgery.