BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS [TM]

    MDR report key: 1250395 · Received December 3, 2008

    Report

    Report Number
    2031924-2008-00323
    Event Type
    Injury
    Date Received
    December 3, 2008
    Report Date
    November 4, 2008
    Manufacturer
    BAUSCH & LOMB SURGICAL
    Product Code
    HQL
    PMA / PMN Number
    P030002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 PHYSICIAN REPORTS THAT DURING CATARACT SURGERY WITH ATTEMPTED IMPLANTATION OF THE CRYSTALENS, THE CAPSULAR BAG WEAKENED AND WOULD NOT SUPPORT THE CRYSTALENS. THE IOL WAS REMOVED INTRAOPERATIVELY AND REPLACED SUCCESSFULLY WITH A DIFFERENT LENS MODEL. THE CAUSE OF THE CAPSULAR BAG WEAKENING IS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYSTALENS [TM] INTRAOCULAR LENS HQL BAUSCH & LOMB SURGICAL HD500 013329

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention