BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 3843619 · Received March 25, 2014

    Report

    Report Number
    2028159-2014-00484
    Event Type
    Malfunction
    Date Received
    March 25, 2014
    Report Date
    February 24, 2014
    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
    RS
    Reporter Occupation
    UNKNOWN

    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 INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER IS REPORTING THE SYSTEM DISPLAYED A SYSTEM MESSAGE, AIR BUBBLES APPEAR FROM THE IRRIGATION SYSTEM AND THE REFLUX MODE DOESN'T WORK. SURGICAL TIMING AND PT INVOLVEMENT ARE UNK. ADDITIONAL INFO HAS BEEN REQUESTED BUT NON HAS BEEN RECEIVED YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174018 CONSTELLATION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON - IRVINE TECHNOLOGY CENTER WITH LASER NA

    Patients

    Seq Age Sex Outcome Treatment
    1