BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 3131502 · Received May 14, 2013

    Report

    Report Number
    2028159-2013-00901
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    April 16, 2013
    Report Date
    April 18, 2013
    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
    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 INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A SYSTEM MESSAGE WAS DISPLAYED AND BALANCED SALT SOLUTION (BSS) WAS LEAKING FROM THE BACK OF THE CASSETTE AND DOWN THE FRONT OF THE SYSTEM DURING A VITRECTOMY PROCEDURE. THE CUSTOMER ALSO REPORTED DAMAGE AROUND THE SCREEN OF THE SYSTEM. FOLLOWING A 15 MINUTE DELAY, THE PROCEDURE WAS COMPLETED WITH NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213666 CONSTELLATION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON - IRVINE TECHNOLOGY CENTER LXT NA

    Patients

    Seq Age Sex Outcome Treatment
    1