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  • Background

    The U.S. Food and Drug Administration (FDA) recently released draft guidance that recommends new labeling requirements for LASIK devices that would serve to promote patient education about the possible side effects of LASIK, a type of refractive surgery.

    Organizations representing the ophthalmic community, including the Academy, have offered comments on this draft guidance.

    Academy Position

    The Academy has offered draft guidance “Laser-Assisted In Situ Keratomileusis (LASIK) — Patient Labeling Recommendations,” to further promote patient education about LASIK surgery. The Academy believes that the guidance includes important topics that are a part of the informed consent process. It is our view that the guidance does not present them with sufficient depth or nuance and that many of the recommendations are duplicative.

    In addition, we believe that several statements within the guidance are not well supportive by existing scientific evidence. The Academy has an extensive history of productive collaboration with the FDA and shares the goal of enhancing patient safety. We hope to be able to work with together to achieve the best process, incorporating the most useful supporting literature, for the benefit of our patients.   

    The topics the guidance document covers are all important for the informed consent process, but they are not presented with sufficient depth and nuance, said Academy CEO Stephen McLeod, MD.

    What We’re Doing

    The Academy believes an informed patient is a better, more satisfied patient. Below are examples of the Academy’s positions on LASIK as well as extensive educational resources to both ophthalmologists and their patients, including:

    • The Academy submitted comments on the FDA’s draft guidance expressing our desire to work with FDA to meet the need for public information without overburdening and duplicating the responsibilities of the physician.
    • The Academy partnered with the FDA 14 years ago to produce this patient guide to refractive surgery: “Is LASIK For Me? A Patient’s Guide to Refractive Surgery
    • The Academy’s EyeSmart® program provides the public with the most trusted information about eye health, including vision correction surgeries such as LASIK: “Questions to Ask When Considering LASIK
    • The Academy offers guidelines to assist ophthalmologists in providing informative advertising for refractive surgery.