Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
VisuMax Software Version 2.10.13 with activated Software-Module ReLEx (SMILE) option Recalled by Carl Zeiss Meditec, Inc. Due to VisuMax devices with software version 2.10.13 and activated...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Carl Zeiss Meditec, Inc. directly.
Affected Products
VisuMax Software Version 2.10.13 with activated Software-Module ReLEx (SMILE) option used in conjunction with the VisuMax Femtosecond Laser System for Refractive Correction. Catalog Number 0000000-1345-518 Product Usage: The VisuMax Femtosecond Laser is a precision ophthalmic surgical laser designed for the creation of incisions in the cornea. The VisuMax Femtosecond Laser is indicated for use in small incision lenticule extraction (SMILE) for the reduction or elimination of myopia. This device is intended for use in small incision lenticule extraction (SMILE) for 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 as demonstrated by a change of <=0.50 D MRSE.
Quantity: 66 units
Why Was This Recalled?
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 allows the user to choose the option immediate restart or restart treatment. Suction loss can occur in phase 1 through phase 5. The software defect refers to Phase 2 (between 10% and 100% of lower lenticule cut) only. The software offers a flap cut, but due to the software issue it performs a cap cut instead of a flap cut if the user proceeds.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Carl Zeiss Meditec, Inc.
Carl Zeiss Meditec, Inc. has 10 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report