BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 3791844 · Received January 22, 2014

    Report

    Report Number
    2028159-2014-00109
    Event Type
    Malfunction
    Date Received
    January 22, 2014
    Date of Event
    December 1, 2013
    Report Date
    December 25, 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
    TU
    Reporter Occupation
    PHYSICIAN

    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 SURGEON REPORTED THAT DURING SURGERY, THE SYSTEM COULD NOT PROVIDE ENOUGH FLUID DURING THE IRRIGATION-ASPIRATION PHASE. THE SPACE IN THE ANTERIOR CHAMBER WAS NOT MAINTAINED. THE EVENT OCCURRED ABOUT 8 TIMES WHEN USING THE DEVICE DURING THE TWO WKS BEFORE REPORTING THE EVENT. THE PTS DID NOT EXPERIENCE ANY CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53502 CONSTELLATION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON - IRVINE TECHNOLOGY CENTER TABLETOP NA

    Patients

    Seq Age Sex Outcome Treatment
    1