BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 3834528 · Received March 19, 2014

    Report

    Report Number
    2028159-2014-00456
    Event Type
    Malfunction
    Date Received
    March 19, 2014
    Report Date
    February 21, 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
    NL
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE HAS BEEN RECEIVED AND IN-HOUSE EVALUATION IS IN PROGRESS. 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. ADDITIONAL INFO HAS BEEN REQUESTED. (B)(4).

    Description of Event or Problem · 1

    HOSP REPORTED THAT DURING FLUID/AIR EXCHANGE NO AIR WAS PROVIDED. WATER/AIR TUBING WAS EXCHANGED AND EVERYTHING WENT WELL. PT IMPACT WAS UNK. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162290 CONSTELLATION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON - IRVINE TECHNOLOGY CTR NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK TOTAL PLUS, 25+ 5.000 CUTS PER MINUTE VALVE