BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 3190751 · Received June 24, 2013

    Report

    Report Number
    2028159-2013-01242
    Event Type
    Malfunction
    Date Received
    June 24, 2013
    Date of Event
    May 24, 2013
    Report Date
    May 28, 2013
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K101285
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT SAMPLE HAS NOT YET BEEN RECEIVED FOR DECONTAMINATION AND EVALUATION; THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED. THE DEVICE HISTORY RECORDS FOR THE COMPONENT LOT WAS REVIEWED. NO ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE COMPLAINT WERE FOUND DURING THE REVIEW. THE ASSOCIATED LOT WAS RELEASED BASED ON THE MANUFACTURER'S ACCEPTANCE CRITERIA. A ROOT CAUSE HAS NOT BEEN DETERMINED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT AIR BUBBLES WERE PRESENT IN THE ASPIRATION LINE WHEN PERFORMING A VITRECTOMY PROCEDURE. THE ASPIRATION PROCEDURE WAS LESS EFFICIENT DUE TO THE AIR BUBBLES. THE PRODUCT WAS EXCHANGED AND THE OPERATION WAS COMPLETED WITHOUT HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286395 CONSTELLATION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON - IRVINE TECHNOLOGY CENTER LXT-JAPAN NA

    Patients

    Seq Age Sex Outcome Treatment
    1 ULTRAVIT 25+ 5000 PAK