Class II — Carl Zeiss Meditec AG
| Recalling firm | Carl Zeiss Meditec AG (Jena) |
|---|---|
| Registered facility | View this company's 13 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | IOL Master software versions 7.5 and 7.7 calculation printouts and exported reports can contain the wrong IOL power data. |
| Product | IOL Master 5.5: Software versions 7.5 and 7.7; Ophthalmic: used to obtain ocular measurements and perform calculations to allow physicians to determine appropriate IOL power and type for implantation. |
| Quantity | 49 |
| Distribution | Nationwide Distribution. |
| Initiated | 2015-10-27 |
| Classified | 2015-12-01 |
| Terminated | 2016-06-06 |
| Recall number | Z-0357-2016 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Carl Zeiss Meditec AG (Z-0357-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/72564/
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