FDA issued draft guidelines and collected comments; eye surgeons debate a need for help vs. ‘fear mongering’
The surgery known as LASIK — Laser-Assisted In Situ Keratomileusis — is under the lens of the Food and Drug Administration (FDA), which is causing controversy among eye experts. The FDA released a 25-page draft guidance after receiving input from patients who felt they were not fully informed of the risks associated with the surgery, the agency stated on its website. The FDA’s guidance states that patients considering LASIK surgery should be given a “decision checklist” that describes the procedure. Patients should also receive a list of potential side effects that may include dry eyes, difficulty driving at night, double vision, seeing halos around objects and in some cases persistent eye pain and a need for glasses, the FDA said in the same paper. The FDA in July presented the draft guidelines, which suggested the content that should be included on patient labeling information for LASIK devices. “It is important for people considering LASIK to have clear and understandable information on the benefits and risks of the surgery to help inform their decision on whether to get LASIK,” the FDA said in the draft guidance. “These recommendations, when finalized, are intended to help ensure physicians can share and patients can understand information about the benefits and risks of LASIK devices,” the agency also said. “Further,” the agency noted, “this information is intended to enhance, but not replace, the physician-patient discussion of the benefits and risks of LASIK devices that may uniquely pertain to individual patients.”
LASIK is a surgery that takes less than 30 minutes to perform; its purpose is to correct vision problems such as nearsightedness, farsightedness and astigmatism. It’s not typically covered by insurance and can cost several thousands of dollars. The goal is to reduce a person’s dependency on eyeglasses and contact lenses, the FDA said on its website. The surgical procedure, said health care experts, uses a type of laser to permanently change the shape of the cornea, which is the covering of the front portion of the eye that refracts light.
Continue the article on FoxNews.com