Sorry Lasik Industry, This Is FDA's Lane
This week in Pedersen's POV, our senior editor takes an unpopular stance on FDA's draft guidance for Lasik eye surgery.
December 19, 2022
Patients considering Lasik eye surgery need to be better informed of the risks associated with the procedure, according to an FDA draft guidance published earlier this year. Suffice is to say the guidance didn't go over well with eye surgeons and medical device manufacturers.
The 29-page document focuses on the risks associated with Lasik and notes that a few patients have become severely depressed – even suicidal – after experiencing complications from the surgery. People with diabetes and certain other chronic conditions may have a higher risk for poor Lasik outcomes, according to the document. Among the agency’s recommendations is a “decision checklist” describing Lasik surgery, highlighting that the corneal tissue is “vaporized” during the procedure and corneal nerves may never recover from incisions, resulting in dry eyes and, in rare cases, chronic pain.
This decision checklist proposal has many in the industry fired up. They claim that such a checklist is regulatory overreach and would interfere with the doctor-patient discussion.