FDA-Device2018-10-24Class II
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
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.
Sold states
US: CA (Mountain View and San Jose) A single system. No distributed OUS.
Affected count
1
Manufactured in
Carl-Zeiss-Promenade 10, N/A, Jena, N/A, Germany
Products
Carl Zeiss Meditec AG, Goeschwitzer Strasse 51-52 07745 Jena, Germany, IOLMaster 700, REF 1932-169 SN 1185393 2017-09-01
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0108-2019Don't want to check this manually?
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