BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 2822718 · Received November 2, 2012

    Report

    Report Number
    2028159-2012-01697
    Event Type
    Malfunction
    Date Received
    November 2, 2012
    Date of Event
    September 25, 2012
    Report Date
    October 4, 2012
    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
    AS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS IN PROGRESS. A SAMPLE IS EXPECTED, BUT HAS NOT YET BEEN RECEIVED FOR EVALUATION. A ROOT CAUSE HAS NOT BEEN IDENTIFIED. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THE TROCULAR INFUSION LINE STOPPED MIDWAY THROUGH SURGERY. THE PROCEDURE WAS COMPLETED WITH NO HARM TO THE PATIENT. ADDITIONAL INORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSTELLATION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON - IRVINE TECHNOLOGY CENTER LXT 1336365H

    Patients

    Seq Age Sex Outcome Treatment
    1 23 GAUGE 5.0 CPM| CONSTELLATION VISION SYSTEM, PRIMARY PAK: