BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILICONE ADVANCED OPTIC-VIOLET SHIELD

    MDR report key: 1070048 · Received July 3, 2008

    Report

    Report Number
    1920664-2008-00719
    Event Type
    Malfunction
    Date Received
    July 3, 2008
    Date of Event
    June 9, 2008
    Report Date
    June 11, 2008
    Manufacturer
    BAUSCH & LOMB
    Product Code
    HQL
    PMA / PMN Number
    P910061
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE LENS DID NOT COME OUT OF THE INSERTER CORRECTLY DURING THE INSERTION IN THE PATIENT'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