BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AKREOS AO MICRO INCISION LENS

    MDR report key: 2191113 · Received July 29, 2011

    Report

    Report Number
    1119279-2011-00142
    Event Type
    Injury
    Date Received
    July 29, 2011
    Date of Event
    April 25, 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 DEVICE IS IMPLANTED, THEREFORE NOT AVAILABLE FOR EVALUATION. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDING THAT RELATE TO THE REPORTED ISSUE. THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE IDENTIFIED. INSPECTION AND TEST RECORDS INDICATE THAT THIS LOT CONFORMED TO SPECIFICATIONS AT THE TIME OF RELEASE.

    Description of Event or Problem · 1

    FIBRIN REACTION WAS OBSERVED 26 DAYS AFTER MI60G IMPLANTATION IN THE RIGHT EYE. PATIENT WAS TREATED POST-OPERATIVELY WITH ANTIBIOTICS AND ANTI-INFLAMMATORY MEDICATION. ON (B)(6) 2011, 41 DAYS AFTER IMPLANTATION, THE PATIENT HAD THE MEMBRANE SURGICALLY REMOVED. PATIENT ALSO HAS CYSTOID MACULAR EDEMA TREATED WITH ORAL AND TOPICAL MEDICATION. THE PATIENT'S BCVA ON (B)(6) 2011 WAS 0.4 (20/50).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AKREOS AO MICRO INCISION LENS INTRAOCULAR LENS HQL BAUSCH + LOMB MI60G 1103916

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention