Recall Z-0357-2016

Carl Zeiss Meditec AG · initiated October 27, 2015

Class II Terminated

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

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.

Codes / lots: 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.

Reason for recall

IOL Master software versions 7.5 and 7.7 calculation printouts and exported reports can contain the wrong IOL power data.

FDA-determined cause: Software design

Action taken

Urgent Medical Device Correction letters will be mailed on Friday, November 13, 2015 as the IOL SW update material is now available. Letter informs customers of the issue and provide instructions for identifying the software version and for installing the software update with illustrations. All customers are requested to complete and return the confirmation form to Stericycle as soon as the upgrade is complete or it has been determined that your unit is not running the affected version of the software.

Details

Recall number
Z-0357-2016
Initiated
October 27, 2015
Posted by FDA
December 1, 2015
Terminated
June 6, 2016
Product code
HJO – Biomicroscope, Slit-Lamp, Ac-Powered
Quantity
49
Distribution
Nationwide Distribution.
Recalling firm
Carl Zeiss Meditec AG, Jena

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-0358-2016 Class IIIOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended…IOL Master software versions 7.5 and 7.7 calculation printouts and exported reports can contain the wrong… 10/27/2015Terminated