BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION

    MDR report key: 1872154 · Received October 14, 2010

    Report

    Report Number
    2028159-2010-01970
    Event Type
    Malfunction
    Date Received
    October 14, 2010
    Date of Event
    September 14, 2010
    Report Date
    September 14, 2010
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K063583
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    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

    THE SURGEON REPORTED THAT THE PHACO CASSETTE WAS LEAKING. THE LEAKAGE WAS FROM THE REAR AREA OF THE ELASTOMERIC MEMBRANE. NO MESSAGE CODE WAS DISPLAYED DURING THE SURGERY AND IT COULD BE COMPLETED. NO PATIENT HARM WAS REPORTED. THE SURGEON IS NOT WILLING TO PROVIDE FURTHER INFO ABOUT THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSTELLATION UNIT, PHACOFRAGMENTATION HQC ALCON - IRVINE TECHNOLOGY CENTER CONSTELLATION 1040293H

    Patients

    Seq Age Sex Outcome Treatment
    1 CONSTELLATION SURGICAL PAK