Z-0357-2016 Class II Terminated
FDA device recall Z-0357-2016 was initiated by Carl Zeiss Meditec AG on October 27, 2015 and is designated Class II. Reason for recall: IOL Master software versions 7.5 and 7.7 calculation printouts and exported reports can contain the wrong IOL power data. The recall status is terminated (terminated June 6, 2016). Affected quantity: 49.
Recall Details
- Product Type
- Devices
- Report Date
- December 9, 2015
- Initiation Date
- October 27, 2015
- Termination Date
- June 6, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 49
Product Description
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.
Reason for Recall
IOL Master software versions 7.5 and 7.7 calculation printouts and exported reports can contain the wrong IOL power data.
Distribution Pattern
Nationwide Distribution.
Code Information
Software versions 7.5 and 7.7: Serial numbers: 1040306 1045450 1035312 1034011 1035310 1043145 1039588 1041805 1040321 1041803 1045443 1036716 1035318 1038800 1034016 1041838 1041833 1039587 1035291 1040313 1038795 1034051 1036553 1040314 1036539 1036702 1043952 1039614 1036541 1043121 1036786 1036713 1045455 1034801 1034792 1034071 1043117 1034795 1045451 1039611 1043941 1036693 1041836 1036532 1043132 1043134 1034073 1034822 1040315.