BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILICONE ADVANCED OPTIC LENS

    MDR report key: 1013798 · Received March 14, 2008

    Report

    Report Number
    1920664-2008-00367
    Event Type
    Injury
    Date Received
    March 14, 2008
    Date of Event
    February 19, 2008
    Report Date
    February 19, 2008
    Manufacturer
    BAUSCH & LOMB
    Product Code
    HQL
    PMA / PMN Number
    P910061
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SEE MDR 1920664-2008-00368 FOR DELIVERY DEVICE USED WITH THIS INTRAOCULAR LENS.

    Description of Event or Problem · 1

    THE HAPTIC BENT DURING THE INSERTION OF THE LENS IN THE PATIENT'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