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Carl Zeiss Meditec AG recalls Carl Zeiss Meditec AG, Goeschwitzer Strasse 51-52 07745 Jena, Germany, IOLMaster 700, REF 1932-169 SN 1185393 2017-09
Recalled October 24, 2018 · FDA recall Z-0108-2019 · Carl Zeiss Meditec AG
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. · FDA Class II
Units
1
Sold at
US: CA (Mountain View and San Jose) A single system. No distributed OUS.
Description
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.
Product
Carl Zeiss Meditec AG, Goeschwitzer Strasse 51-52 07745 Jena, Germany, IOLMaster 700, REF 1932-169 SN 1185393 2017-09-01
Manufacturer(s)
Carl Zeiss Meditec AG
Made in
Germany
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →