BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE MINIATURE TELESCOPE

    MDR report key: 3909136 · Received June 5, 2014

    Report

    Report Number
    3005347768-2014-00001
    Event Type
    Injury
    Date Received
    June 5, 2014
    Manufacturer
    VISIONCARE OPHTHALMIC TECHNOLOGIES LTD.
    Product Code
    NCJ
    PMA / PMN Number
    P050034
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    ANOTHER DEVICE FROM THE SAME BATCH WAS IMPLANTED AT A DIFFERENT USER FACILITY ON (B)(6) 2014 AND NO ADVERSE EVENTS HAVE BEEN REPORTED FOR THIS PT. THE DEVICE HISTORY RECORDS AND STERILIZATION RECORDS WERE REVIEWED FOR THE BATCH OF THE DEVICE INVOLVED AND NO DEVIATIONS WERE FOUND. VISIONCARE BATCHES (B)(4) WERE STERILIZED IN THE SAME STERILIZATION LOAD. SIXTEEN DEVICE FROM THESE BATCHES WERE IMPLANTED IN PTS BETWEEN (B)(6) 2013 AND (B)(6) 2014 AND NO COMPLAINTS HAVE BEEN RECEIVED. STERILIZATION AND DEVICE BIOBURDEN VALIDATION ARE ROUTINELY CARRIED OUT BY VISIONCARE OPHTHALMIC TECHNOLOGIES AND NO DEVIATIONS HAVE BEEN FOUND. A REVIEW OF THE PREVIOUS ADVERSE EVENT REPORTED IN 2012 SHOWED INFECTION BY THE SAME SOURCE-(B)(6). THIS PREVIOUS EVENT WAS A RESULT OF THE PT RUBBING THEIR EYE AS REPORTED BY THE PT'S FAMILY. NO OTHER ADVERSE EVENTS OR COMPLAINTS RESULTING FROM INFECTIONS IN THE EYE HAVE BEEN RECEIVED BY VISIONCARE.

    Description of Event or Problem · 1

    RER IMP # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330237 IMPLANTABLE MINIATURE TELESCOPE NCJ VISIONCARE OPHTHALMIC TECHNOLOGIES LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1