Draft Guidance Issued by FDA to Improve Patient Communication on LASIK Benefits & Risks (Health & Beauty - Health Services)

Item ID 3065017 in Category: Health & Beauty - Health Services

Draft Guidance Issued by FDA to Improve Patient Communication on LASIK Benefits & Risks


LASIK, one of the most popular elective procedures, has long piqued the FDA’s interest. The FDA convened an advisory committee meeting in 2008 to discuss patient labelling. The cornea is permanently altered during the outpatient procedure known as LASIK to change how the eye focuses light onto the retina at the back of the eye. LASIK surgery aims to eliminate the need for eyeglasses and contact lenses by treating common vision problems such as near-sightedness, farsightedness, and astigmatism.

The FDA’s Center for Devices and Radiological Health is headed by Dr. Jeff Shuren says, “It is important to provide patients with comprehensive labeling that clearly describes the risks involved with LASIK surgery, including potential adverse effects such as dry eye, pain and discomfort, and visual symptoms.” Jeff added, “These proposed labeling recommendations, based on extensive consultation with stakeholders and patients, are intended to present information about LASIK in language that is easy to read and understand and include images that convey visual symptoms that could occur following LASIK. The draft guidance is designed to support discussions that patients should have with their eye care providers about the benefits and risks of LASIK to help them make informed decisions before proceeding with the surgery.”

For more details please visit our website - https://www.medhealthreview.com/2025/02/24/draft-guidance-issued-by-fda-to-improve-patient-communication-on-lasik-benefits-risks/


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Target State: New York
Target City : New York City
Last Update : Aug 22, 2025 1:49 AM
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