Zeiss brand IOLMaster — Class II medical device recall Z-0333-2014
Terminated recall by Carl Zeiss Meditec, Inc., reported 2013-11-27, distributed nationwide. The user database delivered for download contained an erroneous value. Specifically the "aO" constant of the l
| Recall number | Z-0333-2014 |
|---|---|
| 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 | 2013-10-23 |
| Classified | 2013-11-15 |
| Reported by FDA | 2013-11-27 |
| Terminated | 2014-04-17 |
| Distributed | Nationwide (US) |
| Quantity | 4,907 units |
| Serial numbers | 1000493, 1000494, 1000495, 1000496, 1000499, 1000500, 1000501, 1000502, 1000503, 1000505, 1000507, 1000508, 1000509, 1000513, 1000515, 1000516, 1000528, 1000529, 1000530, 1000535, 1000536, 1000537, 1000538, 1000539, 1000541 and 475 more |
Product
Zeiss brand IOLMaster, Version 1-5, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA This device is intended for use primarily by physicians and health care workers and may be only used under the supervision of a physician. This device will not be sold to the general public. The IOLMaster is intended for the 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. For patients who are candidates for intraocular lens (IOL) implantation, the device also performs calculations to assist physicians in determining the appropriate IOL power and type for implantation
Reason for recall
The user database delivered for download contained an erroneous value. Specifically the "aO" constant of the lens AMO Sensar AR40E is listed as "0.0" in the internal lens database of the IOLMaster. The correct value is -2.420. This could lead to the implantation of lens with a wrong diopter value.
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-0333-2014. 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.