BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AKREOS ADAPT ADVANCED OPTICS LENS

    MDR report key: 2190663 · Received July 25, 2011

    Report

    Report Number
    1119279-2011-00137
    Event Type
    Injury
    Date Received
    July 25, 2011
    Date of Event
    June 14, 2011
    Report Date
    June 14, 2011
    Manufacturer
    BAUSCH & LOMB
    Product Code
    HQL
    PMA / PMN Number
    P060022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LENS WAS RETURNED TO B+L. VISUAL INSPECTION FOUND THE LENS OPTIC TORN IN HALF WITH TWO HAPTICS ATTACHED TO EACH PIECE OF THE OPTIC. THE HAPTICS ARE NOT DAMAGED. A FUNCTIONAL TEST CANNOT BE PERFORMED DUE TO THE TORN CONDITION OF THE LENS. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDING THAT RELATE TO THE REPORTED ISSUE.

    Description of Event or Problem · 1

    THE SURGEON REPORTED THAT AN ADAPT-AO IOL SPLIT IN HALF DURING IMPLANTATION INTO THE PATIENT'S EYE. THE INCISION HAD TO BE ENLARGED AND THE LENS WAS REMOVED. THE INJECTOR WAS REPORTED AS FEELING SLIGHTLY STIFF. PLEASE REFERENCE MDR#: 11119279-2011-00138.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AKREOS ADAPT ADVANCED OPTICS LENS INTRAOCULAR LENS HQL BAUSCH & LOMB ADAPT-AO 1104728

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention AI-28 DELIVERY DEVICE