BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM

    MDR report key: 4210793 · Received August 1, 2014

    Report

    Report Number
    2028159-2014-01446
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    January 1, 2014
    Report Date
    July 8, 2014
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K021566
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL REPORT 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 MATERIALS MANAGER REPORTED THE UNIT IS SURGING AND THE ASPIRATION IS POOR DURING A PROCEDURE. SURGERY WAS COMPLETED USING AN ALTERNATE SYSTEM WITH NO IMPACT TO THE PT. ADD'L INFO HAS BEEN REQUESTED, BUT NONE HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451754 INFINITI VISION SYSTEM PHACOGRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER INFINITI NA

    Patients

    Seq Age Sex Outcome Treatment
    1