Product Wiki · Recalls · U.S. FDA — Device Enforcement

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 de — recall Z-0680-2020

U.S. FDA — Device Enforcement · United States · 2018-12-06 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0680-2020
Date of alert: 2018-12-06
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Carl Zeiss Meditec, Inc.
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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