BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILICONE ADVANCED OPTIC-VIOLET SHIELD

    MDR report key: 1191290 · Received September 26, 2008

    Report

    Report Number
    1920664-2008-01014
    Event Type
    Malfunction
    Date Received
    September 26, 2008
    Date of Event
    September 2, 2008
    Report Date
    September 2, 2008
    Manufacturer
    BAUSCH & LOMB
    Product Code
    HQL
    PMA / PMN Number
    P910061
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE HAPTIC WAS DAMAGED WHILE LOADING THE LENS INTO THE DELIVERY DEVICE DURING PREPARATION FOR USE.

    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