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ZEISS gets FDA approval for VisuMax SMILE Vision Correction Procedure

The Medical Technology Business Group of ZEISS has secured approval from the US Food and Drug Administration (FDA) for VisuMax SMILE Vision Correction Procedure, the latest advancement in laser eye surgery.

The procedure is being hailed as the latest development in refractive surgery for correcting myopia. It is performed on ZEISS VisuMax femtosecond laser.

It is available present in over 500 clinics in 61 countries around the world. ZEISS claims that over half a million SMILE procedures have already been conducted around the world, since its introduction in 2011.

The technology is now available for surgeons in US expanding their options for laser eye surgery offered to patients.

ZEISS also claims that the pivotal study results submitted to US FDA showed high visual acuity and refractive predictability outcomes in 336 eyes treated in five investigational sites across in US.

Apart from this surgeons also reported that ReLEx SMILE procedure on ZEISS VisuMax femtosecond laser show fast visual recovery with minimal discomfort to patients.

Procedure involves the use of the VisuMax femtosecond laser which creates a thin disc-shaped lenticule within the cornea and then it is removed the surgeon by making a small incision, also made by the laser on the surface of the cornea. The entire procedure uses one laser in the entire treatment.

ZEISS US president and CEO and ophthalmic devices global president Jim Mazzo said: "I thank the surgeons and clinics who have paved the way for ZEISS to be able to bring this new innovative technology to refractive practices throughout the US.

"For the last 5 years, the popularity of SMILE with surgeons and patients outside of the US has continued to grow. With the FDA approval of the VisuMax SMILE procedure, US surgeons now have a new premium laser eye surgery option for their practice and can offer the benefits of SMILE to their patients.

“The VisuMax SMILE procedure from ZEISS – a major evolution in refractive surgery — has the potential to revitalize and grow the entire US refractive surgery market."