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 the agency to send letters to professional organizations “to advise physicians of a black box warning on excimer lasers.”

The petition says the FDA-NIH-Navy study “demonstrated that three months after LASIK eye surgery, up to 45% of patients who had no visual symptoms before LASIK report [them] after LASIK, and up to 30% of patients who had no dry eye symptoms before LASIK report dry eyes after LASIK.” It cites a 2007 published review of data from 12 FDA clinical trials showing that six months after LASIK about 20% of patients reported that visual symptoms and dry eyes were worse than before surgery, much worse than before surgery, moderately severe after surgery, or severe after surgery.

“With millions of people having undergone laser eye surgery with such frequent problems,” the petitioners write, “it follows that there is an epidemic of visual symptoms/night vision problems and dry eyes caused by this unnecessary surgery. Unless the FDA immediately begins to provide adequately strong black box warnings about the risks and adverse effects of laser eye surgery, the epidemic will continue to grow. There have already been several reports of LASIK-related suicide and countless reports of suicidal ideation. A black-box Warning would help reduce the number of such negative outcomes and therefore falls well within the FDA’s mandate of protecting and promoting public health.”