Company:.Carl Zeiss Meditec AG.
Date of Enforcement Report 12/9/2015
IOL Master 5.5: Software versions 7.5 and 7.7; Ophthalmic: used to obtain ocular measurements and perform calculations to allow physicians to determine appropriate IOL power and type for implantation. Recall Number Z-0357-2016
IOL Master software versions 7.5 and 7.7 calculation printouts and exported reports can contain the wrong IOL power data.
Carl Zeiss Meditec AG, Jena, DE on 10/27/2015. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE