BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILICONE ADVANCED OPTIC LENS

    MDR report key: 1000950 · Received February 20, 2008

    Report

    Report Number
    1920664-2008-00229
    Event Type
    Injury
    Date Received
    February 20, 2008
    Date of Event
    January 22, 2008
    Report Date
    January 22, 2008
    Manufacturer
    BAUSCH & LOMB
    Product Code
    HQL
    PMA / PMN Number
    P910061
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SEE MDR 1920664-2008-00230 FOR DELIVERY DEVICE USED WITH THIS THE INTRAOCULAR LENS.

    Description of Event or Problem · 1

    THE LENS STUCK IN THE DELIVERY DEVICE 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 LENS INTRAOCULAR LENS HQL BAUSCH & LOMB

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention