BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 3843582 · Received March 25, 2014

    Report

    Report Number
    2028159-2014-00495
    Event Type
    Malfunction
    Date Received
    March 25, 2014
    Date of Event
    February 24, 2014
    Report Date
    February 27, 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED BY A COMPANY REP AND IS IN TRANSIT TO THE MANUFACTURING SITE FOR INVESTIGATION. 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 SURGEON REPORTED THAT LEAKAGE OCCURRED FROM THE CASSETTE DURING SURGERY. NO HARM TO THE PT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174002 CONSTELLATION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON - IRVINE TECHNOLOGY CTR LXT-JAPAN NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK 25+5.0 CPM VALVED STD J| TPP