BEUDAMED
    FDA Adverse Event Other Summary report: N

    SILICONE ADVANCED OPTIC-VIOLET SHIELD

    MDR report key: 921741 · Received September 26, 2007

    Report

    Report Number
    1920664-2007-01197
    Event Type
    Other
    Date Received
    September 26, 2007
    Date of Event
    August 29, 2007
    Report Date
    August 29, 2007
    Manufacturer
    BAUSCH & LOMB
    Product Code
    HQL
    PMA / PMN Number
    P910061
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SEE MDR 1920664-2007-01198 FOR DELIVERY DEVICE USED WITH THIS LENS.

    Description of Event or Problem · 1

    THE HAPTIC OF THE LENS WAS FOUND BENT DURING INSERTION INTO THE PATIENT'S EYE USING THE DELIVERY DEVICE. ANOTHER LENS WAS USED FOR THE PROCEDURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention