BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 3140191 · Received May 29, 2013

    Report

    Report Number
    2028159-2013-01052
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    May 6, 2013
    Report Date
    May 6, 2013
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K082845
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    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 ADD'L REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT DURING A CATARACT EXTRACTION PROCEDURE, THE SYSTEM KEPT DISPLAYING OCCLUSION, PHACO WAS POOR, AND VACUUM WAS SHOWING AROUND 06 MMHG EVEN THOUGH THE FOOT SWITCH WAS NOT DEPRESSED. THE HANDPIECE WAS REPLACED, BUT THE ISSUE PERSISTED. THE SURGEON USED A SYRINGE AND CANNULA TO ASPIRATE PRIOR AND AFTER LENS INSERTION. THE CASE WAS COMPLETED WITHOUT HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235415 INFINITI VISION SYSTEM OZIL PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER INFINITI OZIL NA

    Patients

    Seq Age Sex Outcome Treatment
    1