BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILICONE ADVANCE OPTIC LENS

    MDR report key: 916722 · Received September 20, 2007

    Report

    Report Number
    1920664-2007-01151
    Event Type
    Injury
    Date Received
    September 20, 2007
    Date of Event
    August 21, 2007
    Report Date
    August 21, 2007
    Manufacturer
    BAUSCH & LOMB
    Product Code
    HQL
    PMA / PMN Number
    P910061
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI

    Narratives

    Additional Manufacturer Narrative · 1

    SEE MDR 1920664-2007-011052 FOR DELIVERY DEVICE USED WITH THIS LENS.

    Description of Event or Problem · 1

    THE LENS STUCK IN THE DELIVERY DEVICE DURING INSERTION INTO THE PATIENT'S EYE. ANOTHER LENS WAS USED FOR THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILICONE ADVANCE OPTIC LENS INTRAOCULAR LENS HQL BAUSCH & LOMB

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention