IOL Master 500: Software versions 7 — Class II medical device recall Z-0358-2016
Terminated recall by Carl Zeiss Meditec AG, reported 2015-12-09, distributed nationwide. IOL Master software versions 7.5 and 7.7 calculation printouts and exported reports can contain the wrong IOL
| Recall number | Z-0358-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Carl Zeiss Meditec AG, Jena, Germany |
| Recall initiated | 2015-10-27 |
| Classified | 2015-12-01 |
| Reported by FDA | 2015-12-09 |
| Terminated | 2016-06-06 |
| Distributed | Nationwide (US) |
| Quantity | 1,882 |
| Reason classes | software |
| Serial numbers | 1034011, 1035310, 1035312, 1038929, 1038930, 1039588, 1040306, 1043145, 1044483, 1044485, 1044487, 1044488, 1044489, 1044490, 1045450, 1045639, 1046055, 1046056, 1046057, 1046343, 1046344, 1046345, 1046353, 1046355, 1046364 and 475 more |
Product
IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil.
Reason for recall
IOL Master software versions 7.5 and 7.7 calculation printouts and exported reports can contain the wrong IOL power data.
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-0358-2016. 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.