BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AKREOS ADAPT AO MICRO INCISION LENS

    MDR report key: 2040984 · Received March 25, 2011

    Report

    Report Number
    1119279-2011-00066
    Event Type
    Injury
    Date Received
    March 25, 2011
    Date of Event
    February 6, 2011
    Report Date
    February 23, 2011
    Manufacturer
    BAUSCH + LOMB
    Product Code
    HQL
    PMA / PMN Number
    P060022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE SURGEON REPORTS PERFORMING CATARACT SURGERY WITH IMPLANTATION OF THE AKREOS MI60G INTRAOCULAR LENS IN THE RIGHT EYE. ONE DAY POSTOPERATIVELY, THE PT'S VISUAL ACUITY WAS 20/20. APPROXIMATELY TWO WEEKS POSTOPERATIVELY, THE PT'S VISUAL ACUITY WAS 20/30 AND THE PT PRESENTED WITH A CLOUDY SUBSTANCE SIMILAR TO FIBRIN APPEARED ON THE FRONT OF THE OPTIC AFFECTING THE PT'S VISUAL ACUITY. A YAG LASER WAS APPLIED AND THE PT'S VISION HAS IMPROVED. THE PT WAS PRESCRIBED AN ANTI-INFLAMMATORY AND ANTIBIOTIC REGIMEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AKREOS ADAPT AO MICRO INCISION LENS INTRAOCULAR LENS HQL BAUSCH + LOMB MI60G 1929932

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other