BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 2945250 · Received February 1, 2013

    Report

    Report Number
    2028159-2013-00153
    Event Type
    Malfunction
    Date Received
    February 1, 2013
    Date of Event
    December 6, 2012
    Report Date
    December 7, 2012
    Manufacturer
    ALCON - IRVINE TECHNOLGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K101285
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S COMPLAINT HISTORY WAS REVIEWED FOR THE PERIOD OF ONE YEAR; THIS IS THE FIRST COMPLAINT FOR THIS REPORTED ISSUE. THIS IS THE FIRST COMPLAINT REPORTED AGAINST THE FINISH GOODS LOT FOR THIS ISSUE AND THE DEVICE HISTORY RECORD (DHR) SHOWS THE PRODUCT WAS RELEASED PER SPECIFICATION. THE RETURNED SAMPLE WAS VISUALLY AND FUNCTIONALLY TESTED AND PASSED TESTING. A SYSTEM REPRESENTING CURRENT SOFTWARE VERSIONS WAS USED TO TEST THE SAMPLE. FURTHERMORE, A BLOCK READER WAS USED TO INTERROGATE THE RFID'S (RADIO FREQUENCY IDENTIFICATION) PROGRAMMED INFORMATION, WHICH WAS FOUND TO BE CORRECT FOR THE BUILD LOT OF THE RFID'S. FOR THIS COMPLAINT IT IS NOT POSSIBLE TO ISOLATE WHERE THE DEVICE MAY HAVE FAILED AT THE TIME OF THE INITIAL REPORT. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THE RFID (RADIO-FREQUENCY IDENTIFICATION) OF THE CUTTER WAS NOT RECOGNIZED BY THE SYSTEM DURING SURGERY. THE CUTTER WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED WITH NO PT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43938 CONSTELLATION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON - IRVINE TECHNOLGY CENTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 25+ GAUGE 5.0 CPM VALVED STANDARD PACK