BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILICONE ADVANCED OPTIC LENS

    MDR report key: 1011428 · Received March 11, 2008

    Report

    Report Number
    1920664-2008-00349
    Event Type
    Injury
    Date Received
    March 11, 2008
    Date of Event
    February 14, 2008
    Report Date
    February 14, 2008
    Manufacturer
    BAUSCH & LOMB
    Product Code
    HQL
    PMA / PMN Number
    P910061
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SEE MDR 1920664-2008-00350 FOR THE DELIVERY DEVICE USED WITH THIS INTRAOCULAR LENS. RESULTS - THE LENS WAS RETURNED WITH ONE OF THE HAPTICS BENT. THE CAUSE OF THE MALFUNCTION CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    THE LENS WAS FOUND DAMAGED AFTER THE INSERTION INTO THE PT'S EYE. THE LENS WAS REMOVED AND REPLACED.

    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 Required Intervention