BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILICONE ADVANCED OPTIC-VIOLET SHIELD

    MDR report key: 1140080 · Received August 28, 2008

    Report

    Report Number
    1920664-2008-00912
    Event Type
    Injury
    Date Received
    August 28, 2008
    Date of Event
    August 4, 2008
    Report Date
    August 5, 2008
    Manufacturer
    BAUSCH & LOMB
    Product Code
    HQL
    PMA / PMN Number
    P910061
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SEE MDR 1920664-2008-00913 FOR THE DELIVERY DEVICE USED WITH THIS INTRAOCULAR LENS.

    Description of Event or Problem · 1

    AFTER IMPLANTING THE LENS, THE DOCTOR NOTICED A SMALL CHIP IN THE OPTIC OF THE LENS. HE REMOVED AND REPLACED THE LENS.

    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 Required Intervention