Recall Z-0680-2020 ยท OTL Femtosecond Laser System For Refractive Correction
Carl Zeiss Meditec, Inc.
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 i
| Date | Dec 6, 2018 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Software design |
| Action | Consignees were notified with an Urgent Medical Device Recall letter dated 12/06/2019. The letter identified affected devices, described the software issue, and provided direction on what steps to take with suction loss in phase 2, until a software update is available. A response form was asked to be returned. Questions can be directed to 877-486-7473. |
| Quantity | 66 units |
| Distribution | US nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.