FDA Asks LASIK Providers to Ensure Advertising Includes Risks

This Week, the FDA sent out a Letter to Eye Care Professionals stressing that all advertising of procedures performed with FDA-approved technology must comply with the agency’s labeling guidelines. In its letter, it made pointed reference to the lasers used for LASIK procedures. Essential to complying with guidelines, the FDA stressed, is ensuring that all advertising includes information about a device’s limitations and risks.

As part of the communication, the FDA said that it was giving doctors 90 days to bring advertising into compliance with the Food, Drug, & Cosmetic Act or face enforcement activities. These enforcement activities may include: warning letters, product seizures, injunctions, and civil money penalty proceedings.

At eyes.com, we are concerned that you understand the benefits and risks of all types of eye surgery, including LASIK. As a result, we include not one, but two pages on risks associated with the procedure.

On our LASIK side effects page, you will read about some of the more common minor side effects many people experience associated with LASIK, including dry eyes, light sensitivity, night vision problems, and temporary loss of visual clarity.

On our LASIK complications page, you will read about some of the more serious but thankfully less common adverse events that people sometimes experience after LASIK surgery, including irregular astigmatism, diffuse lamellar keratitis (DLK), ectasia, over- or under-correction, and severe dry eyes. These complications are serious enough that many have their own pages detailing them so you can fully understand each. Just follow the links on the complications page to read additional information.

We also invite you to look at the FDA’s own pages on LASIK to get the agency’s perspective on risks and complications associated with the procedure.

LASIK is among the most remarkable advances in medical science, giving us the ability to restore vision in people who were previously forced to wear glasses or contacts for life. But it is not without risks, and understanding those risks is essential to making an informed decision about the procedure.

If you have additional information about the benefits and risks of LASIK, please contact a local ophthalmologist to discuss the procedure in person.