Make Your Voice Heard by the Food and Drug Administration

Lasers used to perform LASIK are regulated by the FDA. Lasers must meet safety and efficacy standards established by the Agency. The FDA monitors safety of medical devices in the field, including medical lasers, through its MedWatch program. All adverse events reported through MedWatch are reviewed by the FDA.

Your surgeon may not acknowledge that your problem is serious, but the FDA has defined an adverse event as any problem that has a negative effect on your quality of life. This includes chronic dry eyes and night vision difficulty. If you suffered a serious problem due to LASIK, the FDA wants to know. You can report your experience by filing an online MedWatch report with the FDA.

“We encourage as much information as possible here, because FDA does look at every voluntary report that comes in. If it’s a decrease in vision, if it’s a halo, if it’s a starburst, if it’s a problem with night vision, these types of things would be considered adverse events to FDA, and we would want those reported because it has affected your vision,” said Mary Weick-Brady of the FDA’s Center for Devices and Radiological Health during an interview with National Public Radio.

File a MedWatch report »