BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 4240061 · Received November 4, 2014

    Report

    Report Number
    2028159-2014-02056
    Event Type
    Malfunction
    Date Received
    November 4, 2014
    Date of Event
    October 1, 2014
    Report Date
    October 9, 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
    OH, 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 DIRECTOR OF NURSING REPORTED DURING A PROCEDURE THE ASPIRATION WAS SLUGGISH. THERE WERE NO ERROR CODES REPORTED. THERE WAS NO PT HARM REPORTED. ADDITIONAL INFO HAS BEEN REQUESTED, BUT NONE HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708152 CONSTELLATION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON - IRVINE TECHNOLOGY CENTER LXT

    Patients

    Seq Age Sex Outcome Treatment
    1