BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 3181941 · Received June 17, 2013

    Report

    Report Number
    2028159-2013-01143
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Report Date
    May 20, 2013
    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
    NL
    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 ADD'L REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THE SYS CONTINUOUSLY GAVE AIR DURING VITRECTOMY PROCEDURES INVOLVING THREE PTS. THE CUSTOMER BELIEVED THAT AIR WAS COMING ALONGSIDE THE WHITE CONNECTOR (THE JUNCTION OF THE AIR TUBING AND FLUID TUBING). THE STAFF HAD TO USE ANOTHER CASSETTE TO RESOLVE THE ISSUE EACH TIME. IT WAS NOTED THAT NO SYS MESSAGE CODE WAS DISPLAYED. THERE WAS NO HARM TO THE PTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274150 CONSTELLATION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON - IRVINE TECHNOLOGY CTR TABLETOP NA

    Patients

    Seq Age Sex Outcome Treatment
    1 COMBINED PROCEDURE PAK 25+ 5.0CPM VALVED 0.9| CUSTOM PAK