BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM

    MDR report key: 2852115 · Received November 14, 2012

    Report

    Report Number
    2028159-2012-01827
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    October 12, 2012
    Report Date
    October 15, 2012
    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
    NURSE

    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 INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT ALTHOUGH THE CASSETTE WAS SUCCESSFUL PRIMED DURING SETUP, THE VACUUM WOULD NOT "PULL" DURING SURGERY. THE CASSETTE WAS SWITCHED OUT AND THE CASE WAS COMPLETED WITH NO IMPACT TO THE PT. THIS IS THE SECOND OF TWO REPORTS BEING FILED FOR THIS FACILITY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 ULTRASONIC INFUSION PAK 0.9 MM