ZEISS Receives FDA Approval for the VISUMAX 800 with SMILE pro Software

ZEISS Medical Technology has received the U.S. FDA Approval for the VISUMAX® 800 with SMILE® pro software for surgically treating nearsightedness, with or without astigmatism.

More than 8 million eyes have been treated with SMILE worldwide, which enables faster treatment, creating the lenticule in less than 10 seconds thanks to a faster laser pulse repetition rate of 2 MHz. The ZEISS femtosecond laser also provides greater flexibility for the surgeon and patient, with a smaller footprint and compatibility with a variety of patient beds, adapting to the clinical environment to provide cutting-edge technology without compromise.

With the availability of the VISUMAX® 800 with SMILE® pro software from ZEISS in the U.S., surgeons can utilize a number of workflow enhancements including: the CentraLign® centration aid, a computer-controlled function for easy centration; the OcuLign® cyclotorsion adjustment to help counter cyclotorsion that may occur; and VISULYZE user nomograms to help surgeons collect and analyze patient data, while also providing detailed nomograms and enabling more control during every surgery.

The increasing global adoption of SMILE from ZEISS represents the positive impact the small incision lenticule extraction procedure continues to have on the quality of life for patients,” said Andrew Chang, Head of Global Sales for ZEISS Medical Technology.

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