Company:.Carl Zeiss Meditec AG.
Date of Enforcement Report 12/9/2015
Class lI:
PRODUCT
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
REASON
IOL Master software versions 7.5 and 7.7 calculation printouts and exported reports can contain the wrong IOL power data.
RECALLING FIRM/MANUFACTURER
Carl Zeiss Meditec AG, Jena, DE on 10/27/2015. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
49
DISTRIBUTION
Nationwide
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