Reported Oct 24, 2018 · Terminated
Carl Zeiss Meditec AG, Goeschwitzer Strasse 51-52 07745 Jena, Germany, IOLMaster 700, REF 1932-169 SN 1185393 2017-09-01
Carl Zeiss Meditec AG
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Carl Zeiss Meditec AG · Carl-Zeiss-Promenade 10 · Jena, N/A · N/A
Is this the product you have?
Carl Zeiss Meditec AGGoeschwitzer Strasse 51-52 07745 JenaGermanyIOLMaster 700REF 1932-169 SN 1185393 2017-09-01
- Lot codes and dates
- Model700
- Catalog Number000000-1932-169
- Serial Number1185393
- UDI04049471092080
- Amount recalled
- 1
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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