BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANTABLE MINIATURE TELESCOPE

    MDR report key: 4349843 · Received November 19, 2014

    Report

    Report Number
    3005347768-2014-00002
    Event Type
    Malfunction
    Date Received
    November 19, 2014
    Product Code
    NCJ
    PMA / PMN Number
    P050034
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANOTHER DEVICE FROM THE SAME LOT (10506) WAS IMPLANTED AT A DIFFERENT USER FACILITY ON (B)(6) 2014 AND NO ADVERSE EVENTS HAVE BEEN REPORTED FOR THIS PATIENT. THE DEVICE HISTORY RECORD (DHR) FOR LOT 156 WAS REVIEWED AND NO DEVIATIONS WERE FOUND. SPECIAL ATTENTION WAS PAID TO THE FOLLOWING PROCESSES: INCOMING INSPECTION OF SHORT TUBE AND WINDOWS; BLOWING TEST FIRST AND SECOND WELDING; LEAK TEST RESULTS FROM FIRST AND SECOND LEAK TEST; STERILIZATION PROCESS RECORDS. REVIEW OF MDR, CUSTOMER COMPLAINTS AND RMA HISTORY WAS CARRIED OUT AND NO ISSUES WHICH MAY BE A SOURCE OF A DEVICE PROBLEM WERE FOUND. THE DEVICE WAS EXPLANTED FROM THE PATIENT ON (B)(6) 2014 AND VISIONCARE HAS REQUESTED THAT IT BE RETURNED TO THEM FOR INVESTIGATION.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750612 IMPLANTABLE MINIATURE TELESCOPE TELESCOPE IMPLANTABLE MINIATURE NCJ

    Patients

    Seq Age Sex Outcome Treatment
    1