Carl Zeiss Meditec Ag VISULENS 550 REF 2268-038 — Class II medical device recall Z-0613-2021
Terminated recall by Carl Zeiss Meditec AG, reported 2020-12-23, distributed nationwide. Due to the incorrect DC/DC converter being assembled onto the communication board. As a result the effectivene
| Recall number | Z-0613-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Carl Zeiss Meditec AG, Jena, N/A, Germany |
| Recall initiated | 2020-08-06 |
| Classified | 2020-12-16 |
| Reported by FDA | 2020-12-23 |
| Terminated | 2024-12-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BE, BO, CA, CH, CO, CY, DE, DK, ES, FR, GB, HK, HR, HU, IE, IN, IT, JP, KR, LU, LV, MY, NL, PT, SG, TR, TW, ZA |
| Quantity | 603 units |
| Reason classes | packaging |
| Model numbers | 000000-2227-967, 2268-038 |
Product
Carl 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.
Reason for recall
Due to the incorrect DC/DC converter being assembled onto the communication board. As a result the effectiveness of the communication board cannot be guaranteed in that the safety function of the board would be insufficient resulting in an increased leakage of current and potentially cause electrical shocks to the user.
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-0613-2021. 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.