ZEISS Gains FDA Approval for Visumax® SMILE Vision Correction Procedure

The Medical Technology Business Group of ZEISS announces the introduction in the US of the VisuMax^® Small Incision Lenticule Extraction (SMILE) procedure, the latest advancement in refractive surgery for the correction of myopia. SMILE, a minimally-invasive corneal refractive procedure, performed on the ZEISS VisuMax femtosecond laser, 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.

Pivotal study results submitted to the US FDA in ZEISS’ Pre-Market Approval (PMA) application demonstrated excellent visual acuity and refractive predictability outcomes for the 336 eyes treated at five investigational sites in the US. SMILE, a femtosecond laser-based, minimally-invasive vision correction procedure, is already established in global markets such as Europe, China, Australia, Canada and India.