BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AKREOS ADAPT AO MICRO INCISION LENS

    MDR report key: 2190950 · Received July 28, 2011

    Report

    Report Number
    1119279-2011-00140
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    May 3, 2011
    Report Date
    June 30, 2011
    Manufacturer
    BAUSCH & LOMB
    Product Code
    HQL
    PMA / PMN Number
    P060022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SURGEON REPORTS PT HAS A GOOD PROGNOSIS WITH CURRENT TREATMENT. THE DEVICE REMAINS IMPLANTED, THEREFORE, NOT AVAILABLE FOR EVAL. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDING THAT RELATE TO THE REPORTED ISSUE. BASED IN CURRENT INFO, THE ROOT CAUSE OF THE EVENT CANNOT BE DETERMINED. INSPECTION AND TEST RECORDS INDICATE THAT THE RELEASED LENSES FROM THIS LOT CONFORMED TO SPECIFICATIONS. THE SURGEON COMMENTED THAT THE FLOPPY IRIS MIGHT HAVE BEEN A FACTOR IN THE EVENT DUE TO THE COMPLICATED PROCEDURE.

    Description of Event or Problem · 1

    FIBRIN WAS OBSERVED 44 DAYS AFTER MI60G IMPLANTATION. PT WAS TREATED POST-OPERATIVELY WITH ANTIBIOTICS AND ANTI-INFLAMMATORY MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AKREOS ADAPT AO MICRO INCISION LENS INTRAOCULAR LENS HQL BAUSCH & LOMB MI60G 1102108

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention