Carl Zeiss Meditec announced that it has received FDA approval of a software update to the Zeiss VisuMax femtosecond laser system for the ReLEx SMILE (small-incision lenticule extraction) procedure. With FDA approval, surgeons can now perform SMILE for the correction of myopia in the US.
In September, the FDA approved the VisuMax Femtosecond Laser ReLEx SMILE procedure, which is indicated for use in the reduction or elimination of myopia -1.00 D to -8.00 D, with ≤ -0.50 D cylinder and MRSE -8.25 D in the eye to be treated in patients who are 22 years of age or older with documentation of stable manifest refraction over the past year.
In the SMILE procedure, surgeons correct patients’ refractive errors using the VisuMax to create a thin disc-shaped lenticule within the cornea, which is then removed by the surgeon through a small incision on the surface of the cornea, also created by the laser. SMILE is a flapless procedure, which requires only one laser to perform the entire treatment. The outer corneal layer remains largely intact, contributing to the eye’s stability – both biomechanical and refractive – and to fast visual recovery.
Jon G. Dishler, MD, FACS, was the first doctor to perform the SMILE procedure in North America, and was the medical monitor for the pivotal clinical trial which led to this approval along with other investigators from around the country. In October at the American Academy of Ophthalmology meeting in Chicago, Dr. Disher spoke with EyewireTV about details of the procedure. That video can be viewed here.
ReLEx SMILE can only be performed with the Zeiss VisuMax femtosecond laser. With over 700,000 procedures performed internationally since its introduction in 2011, and offered in approximately 600 clinics in 62 countries around the world, SMILE is a proven laser vision correction procedure with demonstrated safety and effectiveness.