LASIK Activists Petition for Black Box Warning

Copyright Dickinson FDA Webview at www.fdaweb.com. Republished by permission. 01/05/2015 Notwithstanding a recent FDA-NIH-U.S. Navy collaborative study that downplayed LASIK vision-altering surgery risks, three activists petitioned FDA commissioner Margaret Hamburg 12/24/2014 to add a black box warning to the labeling of lasers approved for the procedure. The petition alleges a “high incidence of induced visual symptoms (double vision/ghosting, starbursts, glare, and halos) and dry eyes” and asks […]