BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRYSTALENS

    MDR report key: 1172174 · Received September 17, 2008

    Report

    Report Number
    2031924-2008-00281
    Event Type
    Malfunction
    Date Received
    September 17, 2008
    Report Date
    August 21, 2008
    Manufacturer
    BAUSCH & LOMB SURGICAL
    Product Code
    HQL
    PMA / PMN Number
    P030002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS WERE REVIEWED, AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS.

    Description of Event or Problem · 1

    THE ACCOUNT REPORTS "IOL MALFUNCTION". ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYSTALENS INTRAOCULAR LENS HQL BAUSCH & LOMB SURGICAL AT50SE 012665

    Patients

    Seq Age Sex Outcome Treatment
    1