BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AKREOS ADAPT AO MICRO INCISION LENS

    MDR report key: 1843553 · Received September 22, 2010

    Report

    Report Number
    1119279-2010-00044
    Event Type
    Injury
    Date Received
    September 22, 2010
    Report Date
    August 24, 2010
    Manufacturer
    BAUSCH + LOMB
    Product Code
    HQL
    PMA / PMN Number
    P060022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTS PERFORMING CATARACT (PHACO) SURGERY WITH IMPLANTATION OF THE MI60 INTRAOCULAR LENS. DURING THE SURGERY, THE ANTERIOR CAPSULE WAS TORN LEAVING ONE HAPTIC IN THE ANTERIOR CHAMBER NEAR THE IRIS. EXPLANT OF THE MI60 IS PLANNED AND REPLACEMENT WILL BE WITH A SULCUS FIXATED LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AKREOS ADAPT AO MICRO INCISION LENS INTRAOCULAR LENS HQL BAUSCH + LOMB MI60

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention