BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS ACCOMMODATING IOL

    MDR report key: 3954599 · Received July 16, 2014

    Report

    Report Number
    2031924-2014-00154
    Event Type
    Injury
    Date Received
    July 16, 2014
    Date of Event
    May 29, 2014
    Report Date
    June 16, 2014
    Product Code
    NAA
    PMA / PMN Number
    P030002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, 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 CAPSULAR BAG EXTENDED AND THE LENS BECAME VAULTED/DECENTERED APPROXIMATELY 9 WEEKS POST IMPLANTATION. THE INCISION WAS ENLARGED, THE LENS WAS CUT AND REMOVED AND REPLACED WITH ANOTHER MODEL LENS AND SUTURES WERE USED. THE PATIENT'S STATUS IS DESCRIBED AS ''DOING WELL'' ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415895 CRYSTALENS ACCOMMODATING IOL LENS, INTRAOCULAR, ACCOMODATIVE NAA AT50AO

    Patients

    Seq Age Sex Outcome Treatment
    1 Other