Carl Zeiss Meditec VisuMax Software Version 2.10.13 Recall: Risk of Incorrect Eye Surgery
Carl Zeiss Meditec recalls VisuMax software version 2.10.13 with activated ReLEx (SMILE) option due to potential incorrect corneal cuts during eye surgery. Affected devices may perform cap cuts instead of flap cuts, risking vision complications.
Use caution until it’s fixed
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.
Contact the company
What happened, in plain English
Carl Zeiss Meditec is recalling VisuMax software version 2.10.13 with the ReLEx (SMILE) option because it can cause incorrect corneal cuts during eye surgery. This defect may lead to vision problems if the software performs a cap cut instead of a flap cut during treatment. Read more at govinfonow.com/recall/69376-carl-zeiss-meditec-visumax-software-version-2-10-13-recall.
Source Summary by GovInfoNow · govinfonow.com/recall/69376-carl-zeiss-meditec-visumax-software-version-2-10-13-recall · Updated August 20, 2026 · FDA enforcement record: FDA #Z-0680-2020
Cite this page
“Carl Zeiss Meditec VisuMax Software Version 2.10.13 Recall: Risk of Incorrect Eye Surgery.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69376-carl-zeiss-meditec-visumax-software-version-2-10-13-recall. Based on FDA recall #Z-0680-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0680-2020%22&limit=1).
Why it’s dangerous
The software defect causes the system to perform a cap cut instead of a flap cut during the SMILE procedure when suction is lost in Phase 2 of treatment. This error can lead to vision complications if the procedure is not corrected immediately.
Who’s affected
Patients using VisuMax Femtosecond Laser systems with software version 2.10.13 and activated ReLEx (SMILE) option for myopia correction are most at risk. This includes individuals with myopia between -1.00 D and -8.00 D who have stable vision.
How to tell if you have this one
Check if your VisuMax Femtosecond Laser system has software version 2.10.13 with the ReLEx (SMILE) option activated. Serial numbers listed in the recall include 988123, 988132, and others.
- Brand
Carl Zeiss Meditec- Category
Medical device
What to do — step by step
Check Software Version
Verify your VisuMax software version and whether the ReLEx (SMILE) option is activated.
Contact Manufacturer
Reach out to Carl Zeiss Meditec for guidance on software updates or corrections.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2.2 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
How can I check if my device is affected?
Check your serial number against the list provided in the recall: 988123, 988132, 1008162, etc.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0680-2020 (December 6, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0680-2020 to see it in context.
- Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.