BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTISAN OR VERISYSE PHAKIC LENS

    MDR report key: 3981447 · Received July 25, 2014

    Report

    Report Number
    8040449-2014-00002
    Event Type
    Injury
    Date Received
    July 25, 2014
    Date of Event
    February 26, 2014
    Report Date
    July 25, 2014
    Manufacturer
    OPHTEC BV
    Product Code
    MTA
    PMA / PMN Number
    P030028
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PT PRESENTED 12 YEARS POST IMPLANTATION WITH REDUCED CORNEAL ENDOTHELIAL CELLS. THE CAUSE OF THE REDUCED CELLS COULD NOT BE DETERMINED. THE SURGEON REMOVED THE LENS AS A PRECAUTIONARY MEASURE.

    Description of Event or Problem · 1

    PT PRESENTED 12 YEARS POSTOP WITH CORNEAL CELL LOSS. DEVICE WAS REMOVED AS A PRECAUTION. CAUSE OF CELL LOSS NOT KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436543 ARTISAN OR VERISYSE PHAKIC LENS INTRAOCULAR LENS, 86 MTA MTA OPHTEC BV 204001W 60709

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other