FDAJune 25, 2018device
Carl Zeiss Meditec AG, Goeschwitzer Strasse 51-52 07745 Jena, Germany, IOLMaster 700, REF 1932-169 SN 1185393 2017-09-01
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Terminated
Brands named
carl zeiss meditec agcarlcarl zeiss
UPCs
000000193216904049471092080
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAOPMI LUMERA 300, REF 61372023-08-18
- FDAZEISS Axio Observer 5 microscope, Product material no. 431006-9901-0002022-06-24
- FDAZEISS miLOOP Lens Fragmentation Device REF 303071-9090-000. Used during cataract surgery.2022-03-16
- FDACIRRUS HD-OCT, Models 5000 AngioPlex and 6000 AngioPlex2022-01-14
- FDAChassis Label - "CIRRUS HD-OCT Rx-Only" Product Label Exterior RX - "CIRRUS HD-OCT Model 6000"2021-07-08
- FDAIOLMaster 7002020-12-07
- FDACarl 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.2020-08-06
- FDACarl Zeiss Meditec AG VISUREF150 REF 2227-967 - Product Usage: is a diagnostic instrument used to determine the objective refractive values and keratometric characteristics of the human eye. The results are used to assist the process of prescribing optical aids such as eyeglasses and contact lenses.2020-08-06
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