BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 4042172 · Received July 8, 2014

    Report

    Report Number
    2028159-2014-01278
    Event Type
    Malfunction
    Date Received
    July 8, 2014
    Date of Event
    January 1, 2014
    Report Date
    June 9, 2014
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CTR
    Product Code
    HQC
    PMA / PMN Number
    K101285
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    UNKNOWN

    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 INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED DURING A VITRECTOMY PROCEDURE THE SYSTEM COULD NOT REFLUX. THE SURGEON WAS USING MICRO REFLUX WHICH DID NOT HAVE ENOUGH PRESSURE TO PUSH OUT WHAT WAS IN THE CUTTER. A COMPANY REP CHANGED THE SURGEON'S SETTINGS TO PROPORTIONAL REFLUX AND SURGERY WAS COMPLETED WITH NO HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398388 CONSTELLATION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON - IRVINE TECHNOLOGY CTR LXT NA

    Patients

    Seq Age Sex Outcome Treatment
    1