BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 3102162 · Received May 3, 2013

    Report

    Report Number
    2028159-2013-00868
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Report Date
    April 12, 2013
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K101285
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION, INCLUDING ROOT CAUSE ANALYSIS, IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A VITRECTOMY PROCEDURE THE SURGEON SWITCHED FROM FLUID TO AIR INFUSION, BUT THERE WAS NO AIR COMING FROM THE TUBE AND THE MACHINE DID NOT SHOW ANY ERROR. THE TUBE WAS SWITCHED AND THE PROCEDURE WAS COMPLETED. IT IS UNK IF THERE WERE ANY CONSEQUENCES OR IMPACT TO THE PT AT THIS TIME. ADDITIONAL INFO HAS BEEN REQUESTED FOR THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194509 CONSTELLATION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON - IRVINE TECHNOLOGY CENTER NA NA

    Patients

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