FDA May Issue Warnings About LASIK Surgery

2 min read

Dec. 8. 2022 -- The FDA is reviewing comments on a draft policy that could alter the way Americans see LASIK surgery to improve their vision.

The FDA proposal pushes for warnings about double vision, dry eyes, ongoing pain, and other issues. It even says people might still need eyeglasses after the surgery.

About 500,000 adults opt for the procedure each year. Many people view the procedure as safe and commonplace, The New York Times reported, and that could change if the FDA adopts the advisories.

LASIK, which stands for laser in-situ keratomileusis, is a popular surgery that can correct vision in people who are nearsighted or farsighted or who have astigmatism.

It’s one of many vision correction surgeries that work by reshaping your cornea, the clear front part of the eye, so that light focuses on the retina in the back of your eye.

It takes about 15 minutes per eye and has been performed for about 25 years. It can cost thousands of dollars, and most insurance plans don’t cover it.

Most people report satisfaction with LASIK results.

The Times reported that many ophthalmologists insist it is safe with only rare long-term complications.

“All we’re asking for is balance,” said Vance Thompson, MD, incoming vice president of the American Society of Cataract and Refractive Surgery. “This document mainly emphasizes the dangers and complications of Lasik, with no mention of the advantages, and the tone is negative enough that it will scare patients.”

The FDA draft says some patients become depressed, even considering suicide. Chronic conditions such as diabetes and some prescriptions can put people at risk.

Warnings would benefit consumers, said Paula Cofer, a Florida woman who claims LASIK ruined her vision and caused chronic pain. “Right now, even if patients do research on the internet and see warnings, they think it’s just one or two unhappy people. Now they see it’s the F.D.A. saying this.”