BEUDAMED
    FDA Adverse Event Other Summary report: N

    SILICONE ADVANCE OPTIC LENS

    MDR report key: 892037 · Received August 8, 2007

    Report

    Report Number
    1920664-2007-00912
    Event Type
    Other
    Date Received
    August 8, 2007
    Date of Event
    July 11, 2007
    Report Date
    July 11, 2007
    Manufacturer
    BAUSCH & LOMB
    Product Code
    HQL
    PMA / PMN Number
    P910061
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FORM WAS COMPLETED BY THE MFR. SEE MDR 1920664-2007-00913 FOR THE DELIVERY DEVICE USED WITH THIS LENS.

    Description of Event or Problem · 1

    AFTER THE LENS WAS INSERTED INTO THE PT'S EYE USING THE DELIVERY DEVICE THE HAPTIC WAS FOUND MISSING. THE LENS WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILICONE ADVANCE OPTIC LENS INTRAOCULAR LENS HQL BAUSCH & LOMB

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention