BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AKREOS ADVANCED OPTICS ASPHERIC LENS

    MDR report key: 2003575 · Received February 22, 2011

    Report

    Report Number
    1119279-2011-00042
    Event Type
    Injury
    Date Received
    February 22, 2011
    Date of Event
    October 8, 2010
    Report Date
    January 24, 2011
    Manufacturer
    BAUSCH + LOMB
    Product Code
    HQL
    PMA / PMN Number
    P060022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION OF THE RETURNED LENS FOUND THE OPTIC TORN NEAR THE CENTER. ALL FOUR HAPTICS ARE ATTACHED AND INTACT. THE DELIVERY DEVICE WAS NOT RETURNED. FUNCTIONAL TESTING CANNOT BE PERFORMED DUE TO THE DAMAGE. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS THAT RELATE TO THE REPORTED ISSUE.

    Description of Event or Problem · 1

    THE SURGEON REPORTS A CAPSULAR BAG TEAR AFTER THE LENS IMPLANTATION. THE LENS WAS REMOVED AND AN ANTERIOR CHAMBER LENS WAS SUCCESSFULLY IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AKREOS ADVANCED OPTICS ASPHERIC LENS INTRAOCULAR LENS HQL BAUSCH + LOMB AO60G 1007720

    Patients

    Seq Age Sex Outcome Treatment
    1 Other