VisuMax Software Version 2 — Class II medical device recall Z-0680-2020
Terminated recall by Carl Zeiss Meditec, Inc., reported 2019-12-25, distributed nationwide. VisuMax devices with software version 2.10.13 and activated SW-Module ReLEx (SMILE) option may experience a so
| Recall number | Z-0680-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Carl Zeiss Meditec, Inc., Dublin, CA, United States |
| Recall initiated | 2018-12-06 |
| Classified | 2019-12-13 |
| Reported by FDA | 2019-12-25 |
| Terminated | 2021-02-02 |
| Distributed | Nationwide (US) |
| Quantity | 66 units |
| Reason classes | software |
| Serial numbers | 1008162, 1008173, 1021446, 1080079, 1089462, 1089463, 1105752, 1105765, 1105766, 1105773, 1115905, 1115920, 1115926, 1124475, 1124476, 1124478, 1124480, 1124483, 1136403, 1143784, 1143795, 1154532, 1154534, 1156046, 1156048 and 46 more |
| Model numbers | 0000000-1345-518 |
Product
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 in small incision lenticule extraction (SMILE) for the reduction or elimination of myopia. This device is intended for use in small incision lenticule extraction (SMILE) for the reduction or elimination of myopia >=-1.00 D to <=-8.00 D, with <=-0.50 D cylinder and MRSE <=-8.25 D in the eye to be treated in patients who are 22 years of age or older with documentation of stable manifest refraction over the past year as demonstrated by a change of <=0.50 D MRSE.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0680-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.