Are These Medical Devices Too Dangerous? (Excimer Lasers for LASIK Surgery)

Posted in Regulatory and Compliance by Jamie Hartford on April 11, 2014

Excimer Lasers for LASIK Surgery

Excimer lasers are used in LASIK surgery to reshape the cornea in order to improve eyesight. Hundreds of thousands of U.S. patients undergo LASIK procedures each year, and to date FDA has approved more than 30 excimer lasers for LASIK. But risks of the procedure include permanent loss of vision; dry eyes; glare, halows, starbursts in vision; and reduced vision in dim-light settings; and need for repeat treatment, according to the agency.

Activists Say:

The fact that retreatments are commonly performed after LASIK speaks to lack of efficacy of the first LASIK procedure, and adds to an already vast body of evidence that use of excimer lasers for LASIK never merited FDA approval.”

—Lasik Surgery Watch letter to CDRH director Jeffrey Shuren 

Industry Says:

LASIK has been shown to be a safe and effective procedure for the correction of refractive errors by numerous studies around the world. It has a low complication rate that is acceptable to many patients and comparable to that of contact lenses over a lifetime. ”

R. Doyle Stulting, M.D., Ph.D., president of the American Society of Cataract and Refractive Surgery, in a letter to Morris Waxler, former chief scientist in charge of the clinical trials research for laser eye surgery who became an anti-LASIK activist

FDA Actions:

1998: Approved first excimer laser system for LASIK procedures. 

2008: Convened public advisory panel to listen to patient experiences and consider ways to improve patient and physician infomraiton about LASIK. Opened public docket for LASIK comments. 

2009: Created LASIK Quality of Life Project, a joint study with the National Eye Institute and the Department of Defense to examine LASIK's impact on quality of life. Sent warning letters to 17 LASIK ambulatory surgical centers for inadequate adverse event reporting systems. Recognized ANSI "Laser Systems for Corneal Reshaping" standard.

2011: Posted video on to explain risks of LASIK. (see below)

Medtronic INFUSE

Stryker Wingspan Stent System



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