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

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/

May 3rd, 2008

The News & Observer 04/26/2008 - Panel wants warning for lasik users

“After listening to hours of patient horror stories Friday, an advisory panel recommended that federal regulators strengthen safety warnings for vision-correcting laser eye surgery. The panel recommended that laser manufacturers add several risk factors to their patient information and that the Food and Drug Administration improve its online consumer information about who is not a good candidate for the surgery.  But the recommendations fell short of patient requests. Some want the FDA to temporarily stop the procedures or include stronger precautions, such as warnings about slow and incomplete healing of the surgical incision and the risks of serious night driving problems…  A published review of safety data for all FDA-approved ophthalmic lasers showed that six months after the surgery, 17.5 percent of patients reported halos in their vision, 19.3 percent had night-driving problems and 21 percent complained of eye dryness.”

Read article at http://www.newsobserver.com/business/story/1050641.html

May 3rd, 2008