Company: Carl Zeiss Meditec AG
Date of Enforcement Report: 2/24/2021
Class II
PRODUCT
IOLMaster 700
Recall Number: Z-1133-2021
REASON
When using software 1.90.2.09 or 1.90.8.06 and using modality worklist functionality for patient data transfer, the selection of the patient in the patient list may not match the patient information displayed on the right side of the screen.
RECALLING FIRM/MANUFACTURER
Carl Zeiss Meditec AG on 12/7/2020. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
613 devices
DISTRIBUTION
U.S. Nationwide and International