medical Class II Updated 2018-10-24

Carl Zeiss Meditec AG recalls Carl Zeiss Meditec AG, Goeschwitzer Strasse 51-52 07745 Jena

Recalled Product

Carl Zeiss Meditec AG, Goeschwitzer Strasse 51-52 07745 Jena, Germany, IOLMaster 700, REF 1932-169 SN 1185393 2017-09-01

Hazard / Issue

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.

Issued by

FDA

Affected States: CA
Lot/Code Info: Model: 700 Catalog Number: 000000-1932-169 Serial Number: 1185393 UDI: 04049471092080
View official government recall

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