FDA approves VisuMax Femtosecond Laser for the small incision lenticule extraction (SMILE) procedure to reduce or eliminate nearsightedness. -Zeiss

The FDA has approved the VisuMax Femtosecond Laser from ZEISS, for the small incision lenticule extraction (SMILE) procedure to reduce or eliminate nearsightedness in certain patients 22 years of age or older. Not all patients are candidates for SMILE, and individuals should carefully review the patient labelling and discuss their expectations with their eye care professional. Nearsightedness, or myopia, is a common vision condition in which close objects are seen clearly, but objects farther away are blurred. It occurs when the eye focuses light in front of the retina. This can be due to the shape of the cornea being too steep and/or the length of the eyeball being too long.

Comment: SMILE, a minimally-invasive corneal refractive procedure, is currently available in approximately 500 clinics in 61 countries around the world. More than a half a million SMILE procedures have been performed internationally since its introduction in 2011 with extensive study results demonstrating high levels of safety and effectiveness. This next evolution in refractive technology is now available to US surgeons expanding the options for laser eye surgery that they can offer to their patients.