BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 4071233 · Received September 2, 2014

    Report

    Report Number
    2028159-2014-01605
    Event Type
    Malfunction
    Date Received
    September 2, 2014
    Date of Event
    August 1, 2014
    Report Date
    August 4, 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
    FL, US
    Reporter Occupation
    OTHER

    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 NURSE REPORTED A SYSTEM MESSAGE DISPLAYED AND THERE WAS NO IRRIGATION FROM THE HANDPIECE WHEN SETTING UP FOR A PROCEDURE. THE HANDPIECE AND CASSETTE WERE EXCHANGED TO TROUBLE SHOOT, BUT THE ISSUES REMAINED. THEY EXCHANGED THE SYSTEM TO PERFORM THE CASE. THERE WAS NO PT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532326 CONSTELLATION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON - IRVINE TECHNOLOGY CENTER LXT NA

    Patients

    Seq Age Sex Outcome Treatment
    1