BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AKREOS ADVANCED OPTICS ASPHERIC LENS

    MDR report key: 3133358 · Received May 24, 2013

    Report

    Report Number
    1119279-2013-00167
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    February 14, 2013
    Report Date
    April 24, 2013
    Manufacturer
    BAUSCH + LOMB
    Product Code
    HQL
    PMA / PMN Number
    P060022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 PATIENT PRESENTED WITH DECREASE IN VISION AND LENS POSTERIOR VAULT ONE MONTH AFTER IMPLANTATION. APPROXIMATELY TWO MONTHS POST-OP, THE SURGEON PERFORMED A YAG PROCEDURE FOLLOWED BY VITRECTOMY AND THE LENS WAS REMOVED AND REPLACED WITH A DIFFERENT MODEL LENS PLACED IN THE SULCUS. THE PATIENT'S CURRENT PROGNOSIS POST IOL EXCHANGE REPORTED AS, PATIENT IS HAPPY. THIS REPORT PERTAINS TO THE PATIENT'S LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231785 AKREOS ADVANCED OPTICS ASPHERIC LENS HQL/INTRAOCULAR LENS HQL BAUSCH + LOMB AO60G 1223001

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other