BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AKREOS ADVANCED OPTICS ASPHERIC LENS

    MDR report key: 3123615 · Received May 17, 2013

    Report

    Report Number
    1119279-2013-00155
    Event Type
    Injury
    Date Received
    May 17, 2013
    Date of Event
    April 17, 2013
    Report Date
    April 18, 2013
    Manufacturer
    BAUSCH + LOMB
    Product Code
    HQL
    PMA / PMN Number
    P060022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE LENS HAS BEEN RETURNED TO B+L AND IS CURRENTLY UNDER EVALUATION. INVESTIGATION OF THIS EVENT IS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LENS WAS INTRAOPERATIVELY REMOVED FROM THE PATIENT'S LEFT EYE ONE HAPTIC APPEARED UNUSUAL TO THE SURGEON. THE INCISION WAS ENLARGED TO REMOVE THE LENS AND SUTURES WERE USED TO CLOSE THE WOUND. A BACK UP LENS OF SAME MODEL WAS IMPLANTED SUCCESSFULLY. THE PATIENT'S PROGNOSIS WAS REPORTED AS NORMAL. PLEASE REFERENCE MDR#: 1119279-2013-00156 FOR THE DELIVERY DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219335 AKREOS ADVANCED OPTICS ASPHERIC LENS HQL/INTRAOCULAR LENS HQL BAUSCH + LOMB AO60G 1113717

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other VISCOJECT 1.8 DELIVERY SYSTEM