BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISIOIN SYSTEM

    MDR report key: 4253255 · Received November 13, 2014

    Report

    Report Number
    2028159-2014-02097
    Event Type
    Malfunction
    Date Received
    November 13, 2014
    Date of Event
    October 16, 2014
    Report Date
    October 17, 2014
    Manufacturer
    ALCON-IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K101285
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NOT APPLICABLE

    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 REPORTED EXPERIENCING POOR ASPIRATION DURING A VITRECTOMY PROCEDURE. THE CASE WAS COMPLETED USING THE SAME EQUIPMENT. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732676 CONSTELLATION VISIOIN SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON-IRVINE TECHNOLOGY CENTER B NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK