BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILICONE ADVANCED OPTIC-VIOLET SHIELD

    MDR report key: 1013788 · Received March 14, 2008

    Report

    Report Number
    1920664-2008-00377
    Event Type
    Injury
    Date Received
    March 14, 2008
    Date of Event
    February 20, 2008
    Report Date
    February 20, 2008
    Manufacturer
    BAUSCH & LOMB
    Product Code
    HQL
    PMA / PMN Number
    P910061
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SEE MDR 1920664-2008-00378 FOR THE DELIVERY DEVICE USED WITH THIS INTRAOCULAR LENS.

    Description of Event or Problem · 1

    THE HAPTIC KINKED DURING THE INSERTION OF THE LENS INTO THE PATIENT'S EYE. THE LENS WAS REMOVED AND REPLACED.

    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