FDA encourages LASIK patients with visual symptoms (halos, starbursts, night vision problems) to file an adverse event report

May 3rd, 2008

National Public Radio 5/1/2008

 The FDA says it’s not certain how many LASIK patients have problems with their vision weeks or months after their surgeries. But the agency is planning a new study, scheduled to begin next year, to get a better handle on the prevalence. Individual consumers can also report their LASIK complications directly to the FDA. (To report complications, click here or call 1-800-FDA-1088.) “We encourage as much information as possible here, because FDA does look at every voluntary report that comes in,” says Mary Weick-Brady of the FDA’s Center for Devices and Radiological Health. The agency uses patient reports to help determine if some new action is needed. “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,” says Weick-Brady.

Full article at http://www.npr.org/templates/story/story.php?storyId=90070220

To report an adverse outcome from LASIK to the FDA, click here https://www.accessdata.fda.gov/scripts/medwatch/

Entry Filed under: Media Reports