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 desig...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Terminated
Brands named
UPCs
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAOPMI LUMERA 300, REF 61372023-08-18
- FDAZEISS Axio Observer 5 microscope, Product material no. 431006-9901-0002022-06-24
- FDAZEISS miLOOP Lens Fragmentation Device REF 303071-9090-000. Used during cataract surgery.2022-03-16
- FDACIRRUS HD-OCT, Models 5000 AngioPlex and 6000 AngioPlex2022-01-14
- FDAChassis Label - "CIRRUS HD-OCT Rx-Only" Product Label Exterior RX - "CIRRUS HD-OCT Model 6000"2021-07-08
- FDAIOLMaster 7002020-12-07
- FDACarl Zeiss Meditec Ag VISULENS 550 REF 2268-038 - Product Usage: is a device for measuring the refractive power of contact lenses and spectacle lenses and displaying measurement values for sphere, cylinder and prism.2020-08-06
- FDACarl Zeiss Meditec AG VISUREF150 REF 2227-967 - Product Usage: is a diagnostic instrument used to determine the objective refractive values and keratometric characteristics of the human eye. The results are used to assist the process of prescribing optical aids such as eyeglasses and contact lenses.2020-08-06
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