BEUDAMED
    FDA Recall 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.

    Recall: Z-0357-2016 · Initiated October 27, 2015

    Recall

    Recall Number
    Z-0357-2016
    Event Number
    72564
    Firm
    Carl Zeiss Meditec AG Carl Zeiss Promenade 10 Jena Germany
    FEI Number
    3001362763
    Product Code
    HJO
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    October 27, 2015
    Posted
    December 1, 2015
    Terminated
    June 6, 2016

    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

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

    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.

    Distribution

    Nationwide Distribution.

    Quantity

    49