BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILICONE ADVANCED OPTIC-VIOLET SHIELD

    MDR report key: 1022434 · Received March 26, 2008

    Report

    Report Number
    1920664-2008-00403
    Event Type
    Malfunction
    Date Received
    March 26, 2008
    Date of Event
    February 25, 2008
    Report Date
    February 27, 2008
    Manufacturer
    BAUSCH & LOMB
    Product Code
    HQL
    PMA / PMN Number
    P910061
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE HAPTIC OF THE LENS WAS FOUND BENT DURING THE INSERTION IN THE PT'S EYE. ANOTHER LENS WAS USED TO COMPLETE 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