BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 2913477 · Received January 9, 2013

    Report

    Report Number
    2028159-2013-00025
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    December 3, 2012
    Report Date
    December 10, 2012
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CTR
    Product Code
    HQC
    PMA / PMN Number
    K101285
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT RETURN A SAMPLE FOR EVALUATION. NO LOT NUMBER WAS IDENTIFIED WITH THIS COMPLAINT; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. BECAUSE A SAMPLE WAS NOT RETURNED WITH THIS COMPLAINT, THE ROOT CAUSE CANNOT BE DETERMINED. IT SHOULD BE NOTED THAT REFLUX IS EXTERNALLY INDUCED FOR THE VITRECTOMY PROBE AND NOT AN INVOLUNTARY FUNCTION OF THE PROBE. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT THE "VITREOTOM REFLUXED" DURING SURGERY. THE PROCEDURE WAS COMPLETED WITH ANOTHER PAK WITH NO IMPACT TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE IS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12077 CONSTELLATION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON - IRVINE TECHNOLOGY CTR NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 PRIMARY PAK 23 GUAUGE 5.0 CPM