BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM

    MDR report key: 3880537 · Received April 9, 2014

    Report

    Report Number
    2028159-2014-00626
    Event Type
    Malfunction
    Date Received
    April 9, 2014
    Date of Event
    March 13, 2014
    Report Date
    March 13, 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
    CI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A PRODUCT SAMPLE WAS RECEIVED AND IT IS AWAITING EVALUATION. 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 SURGEON REPORTED THAT THERE WAS LACK OF ASPIRATION NOTED DURING A CATARACT PROCEDURE. THE REPORTER INFORMED THAT IT WAS NECESSARY TO CHANGE THE FLUIDICS MANAGEMENT SYSTEM TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT HARM REPORTED AS THE PROCEDURE WAS COMPLETED WITHOUT ADDITIONAL PROBLEMS. ADDITIONAL DETAILS HAVE BEEN REQUESTED FOR THIS CASE, HOWEVER, NO NEW INFORMATION HAS BEEN RECEIVED DESPITE SEVERAL FOLLOW UP ATTEMPTS MADE. A PRODUCT SAMPLE WAS RECEIVED AND IT IS AWAITING EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214189 INFINITI VISION SYSTEM PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER INFINITI NA

    Patients

    Seq Age Sex Outcome Treatment
    1