BEUDAMED
    FDA Recall Open, Classified

    Eyesuite 9.3.1 software, LENSTAR, MODEL LS900: ac-powered slit-lamp biomicroscope.

    Recall: Z-1560-2021 · Initiated April 15, 2021

    Recall

    Recall Number
    Z-1560-2021
    Event Number
    87766
    Firm
    Haag-Streit USA Inc
    FEI Number
    1000136533
    Product Code
    HJO
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    April 15, 2021
    Address
    3535 Kings Mills Rd, Mason, OH, 45040-2303

    Description

    Eyesuite 9.3.1 software, LENSTAR, MODEL LS900: ac-powered slit-lamp biomicroscope.

    Reason

    Examination data and patient name may be mixed up when printing or generating a pdf with the interface at Pacific Coast and Laser Institute (PCLI).

    Action

    On 04/06/2021, Haag-Streit issued an Urgent Medical Device Correction notice to their customer via letter notifying them Eyesuite 9.3.1 software may mix up examination data and patient name when printing or generating a PDF.

    Distribution

    US Nationwide distribution in the state of WA.