BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 2803011 · Received October 19, 2012

    Report

    Report Number
    2028159-2012-01596
    Event Type
    Malfunction
    Date Received
    October 19, 2012
    Report Date
    September 20, 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
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A CUSTOMER REPORTED NO AIR OUTPUT DURING SURGERY. AFTER THE SYSTEM WAS EXCHANGED, THE PROCEDURE WAS COMPLETED WITH NO HARM TO THE PT. ADD'L INFO 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 NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1