Carl Zeiss Meditec AG — Class II medical device recall Z-0108-2019
Terminated recall by Carl Zeiss Meditec AG, reported 2018-10-24, distributed in CA. Calibration setting was incorrectly entered during manufacturing causing the optical coherence tomography (OCT
| Recall number | Z-0108-2019 |
|---|---|
| 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 | 2018-06-25 |
| Classified | 2018-10-15 |
| Reported by FDA | 2018-10-24 |
| Terminated | 2021-01-15 |
| Distributed | CA |
| Quantity | 1 |
| UPC / GTIN / UDI-DI | 04049471092080 |
| Serial numbers | 1185393 |
| Model numbers | 000000-1932-169, 1185393, 1932-169, 700 |
Product
Carl Zeiss Meditec AG, Goeschwitzer Strasse 51-52 07745 Jena, Germany, IOLMaster 700, REF 1932-169 SN 1185393 2017-09-01
Reason for recall
Calibration setting was incorrectly entered during manufacturing causing the optical coherence tomography (OCT) to obtain the incorrect two-dimensional images of ocular structures of the anterior and posterior segments of the eye.
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-0108-2019. 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.