BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 3042924 · Received March 5, 2013

    Report

    Report Number
    2028159-2013-00330
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Date of Event
    January 30, 2013
    Report Date
    February 7, 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SAMPLE HAS BEEN REC'D BUT HAS NOT YET BEEN EVALUATED. 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

    AN OPHTHALMIC SURGEON REPORTED AIR IN THE IRRIGATION LINE DURING THE IRRIGATION MODE OF A PROCEDURE. THE SURGEON CLAMPED THE LINE AND COMPLETED THE PROCEDURE WITH NO HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94765 CONSTELLATION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON - IRVINE TECHNOLOGY CTR WITH LASER NA

    Patients

    Seq Age Sex Outcome Treatment
    1 TOTAL PLUS PAK 25+5.0 CPM VALVED STANDARD