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Terminated

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.

FDA Recall Z-0357-2016 · Posted 2015-12-01

Recalling FirmCarl Zeiss Meditec AG
Recall StatusTerminated
Product CodeHJO
Date Initiated2015-10-27
Date Terminated2016-06-06
Product Quantity49

Reason for Recall

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

Firm Action

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.

Root Cause

Software design

Distribution Pattern

Nationwide Distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K122418IOLMASTER 500Carl Zeiss Meditec, AG · 2013-04-12K101182IOLMASTER 500Carl Zeiss Meditec, AG · 2010-11-03K993357IOLMASTERCarl Zeiss, Inc. · 2000-03-20

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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