BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AKREOS ADAPT AO MICRO INCISION LENS

    MDR report key: 1991170 · Received February 7, 2011

    Report

    Report Number
    1119279-2011-00004
    Event Type
    Injury
    Date Received
    February 7, 2011
    Date of Event
    August 29, 2008
    Report Date
    November 3, 2010
    Manufacturer
    BAUSCH & LOMB
    Product Code
    HQL
    PMA / PMN Number
    P060022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS WERE REVIEWED AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDING THAT RELATE TO THE REPORTED ISSUE. THE INTRAOCULAR LENS IS IMPLANTED. (B)(4).

    Description of Event or Problem · 1

    BAUSCH + LOMB RECEIVED A PUBLISHED LITERATURE BY A SURGEON WHO REPORTS PERFORMING CATARACT SURGERY WITH IMPLANTATION OF THE AKREOS MI60G INTRAOCULAR LENS IN THE LEFT EYE. APPROXIMATELY ONE WEEK POSTOPERATIVELY, AN ANTERIOR MEMBRANOUS CHAMBER INFLAMMATION WAS NOTED WHICH WAS SUCCESSFULLY TREATED WITH ANTI-INFLAMMATORY AND ANTIBIOTIC REGIMEN. PREOPERATIVELY, THE PATIENT'S BCVA WAS 20/100 WITH MR -5.50. POSTOPERATIVELY AND AFTER TREATMENT, THE PATIENT'S BCVA WAS 20/20 WITH MR +1.00 + 0.50 X 165.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AKREOS ADAPT AO MICRO INCISION LENS INTRAOCULAR LENS HQL BAUSCH & LOMB MI60G 1731921

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention VISCOJECT 1.8 DELIVERY DEVICE (B+L)