Company:.Carl Zeiss Meditec AG.
Date of Enforcement Report 12/9/2015
IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil.
Recall Number Z-0358-2016
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