BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILICONE ADVANCED OPTIC LENS

    MDR report key: 1760591 · Received July 14, 2010

    Report

    Report Number
    1920664-2010-00187
    Event Type
    Injury
    Date Received
    July 14, 2010
    Date of Event
    April 13, 2010
    Report Date
    July 7, 2010
    Manufacturer
    BAUSCH & LOMB, INC.
    Product Code
    HQL
    PMA / PMN Number
    P910061
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SEE MDR 1920664-2010-00188 FOR THE DELIVERY DEVICE USED WITH THIS INTRAOCULAR LENS.

    Description of Event or Problem · 1

    THE LENS WAS IMPLANTED WHEN THE DOCTOR NOTICED THE HAPTIC WAS BENT. THE INCISION WAS ENLARGED TO REMOVE AND REPLACE THE LENS AND SUTURE WAS USED TO CLOSE THE WOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILICONE ADVANCED OPTIC LENS HQL BAUSCH & LOMB, INC. LI61AOR 4000710

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention BAUSCH + LOMB EZ-28 INSERTER