VISUMAX

Carl Zeiss Meditec AG · Model VISUMAX 800 or 09511 · UDI-DI 04049471095111

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510(k) clearances

Adverse events

Recalls

Facilities

Description

The VISUMAX is a femtosecond laser. It generates a beam of ultra-short laser pulses which are guided through the aperture in the treatment objective . The optical system focuses the laser beam into the corneal tissue. The VISUMAX Femtosecond Laser is indicated for use in small incision lenticule extraction (SMILE) for the reduction or elimination of myopia with or without astigmatism • for spherical refractive error (in minus cylinder format) from -1.00 diopters through -10.00 diopters, • for cylinder from -0.75 diopters through -3.00 diopters, • when refraction spherical equivalent is no greater in magnitude than 10.00 diopters, in patients 22 years of age or older with documentation of stable manifest refraction over the past year as demonstrated by a change in sphere and cylinder of lower or equal 0.50 D in magnitude.

Recalls

Date	Firm	Reason
2018-12-06	Carl Zeiss Meditec, Inc.	VisuMax devices with software version 2.10.13 and activated SW-Module ReLEx (SMILE) option may experience a software issue. In case of a suction loss during treatment the software

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.