BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AKREOS ADAPT AO MICRO INCISION LENS

    MDR report key: 1913900 · Received November 30, 2010

    Report

    Report Number
    1119279-2010-00105
    Event Type
    Injury
    Date Received
    November 30, 2010
    Date of Event
    October 7, 2010
    Report Date
    November 4, 2010
    Manufacturer
    BAUSCH & LOMB
    Product Code
    HQL
    PMA / PMN Number
    P060022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO B+L AND SUBJECTED TO VISUAL INSPECTION. RESULTS REVEALED THAT THE OPTIC OF THE LENS WAS TORN AND CUT IN HALF. THE LENS DAMAGE IS CONSISTENT WITH LENSES THAT HAVE BEEN REMOVED FROM THE EYE.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTS PERFORMING CATARACT SURGERY WITH ATTEMPTED IMPLANTATION OF THE AKREOS (B)(4) INTRAOCULAR LENS IN THE LEFT EYE. AFTER THE LENS WAS INSERTED THE PHYSICIAN OBSERVED THAT THE CAPSULE WAS NOT STABLE AND ELECTED TO REMOVE THE IOL. UPON REMOVAL OF THE LENS A CAPSULE TEAR WAS DETECTED: THE SURGEON PREFORMED AN ANTERIOR VITRECTOMY AND SUCCESSFULLY IMPLANTED AN ANTERIOR CHAMBER INTRAOCULAR LENS. ONE SUTURE WAS REQUIRED TO CLOSE THE INCISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AKREOS ADAPT AO MICRO INCISION LENS INTRAOCULAR LENS HQL BAUSCH & LOMB MI60LUS 1015209

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention