BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 4240062 · Received November 4, 2014

    Report

    Report Number
    2028159-2014-02054
    Event Type
    Malfunction
    Date Received
    November 4, 2014
    Date of Event
    October 10, 2014
    Report Date
    October 10, 2014
    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
    PO
    Reporter Occupation
    NURSE

    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 ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT DURING A VITREAL-RETINAL SURGERY FOR A RETINAL DETACHMENT, LEFT EYE, THE VITRECTOMER STOPPED WORKING BECAUSE THE BLACK PNEUMATIC CONNECTOR BROKE. THE PRODUCT WAS REPLACED WITH ANOTHER PAK. NO PATIENT HARM WAS REPORTED. NO ADDITIONAL INFORMATION IS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707807 CONSTELLATION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON ¿ IRVINE TECHNOLOGY CENTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK STANDARD, 0.9 MM| 23 GAUGE COMBINED PAK, 5000 CUST/MIN, VALVED