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.
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.
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.
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.
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.
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.
Verify your VisuMax software version and whether the ReLEx (SMILE) option is activated.
Reach out to Carl Zeiss Meditec for guidance on software updates or corrections.
VisuMax software version 2.10.13 with activated ReLEx (SMILE) option.
The software may perform a cap cut instead of a flap cut, potentially causing vision complications.
Check your serial number against the list provided in the recall: 988123, 988132, 1008162, etc.
We’ve drafted a message you can send Carl Zeiss Meditec to request your refund or repair — edit it as you like.
Subject: Recall Z-0680-2020 — Carl Zeiss Meditec Carl Zeiss Meditec Hello, I own a Carl Zeiss Meditec that is covered by recall Z-0680-2020 from Carl Zeiss Meditec. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
