BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 1712348 · Received May 28, 2010

    Report

    Report Number
    2028159-2010-00735
    Event Type
    Malfunction
    Date Received
    May 28, 2010
    Date of Event
    April 28, 2010
    Report Date
    April 28, 2010
    Manufacturer
    ALCON - IRVINCE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K082845
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY SERVICE REPRESENTATIVE EXAMINED THE SYSTEM. THE FILTERS WERE CLEANED. THE FLUIDICS WASHERS WERE REPLACED AND DISPOSED OF. THE HANDPIECES WERE CHECKED WITH NO PROBLEMS FOUND. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. (B) (4). (B) (4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "NO PATIENT INJURY REPORTED" (NO CONSEQUENCES OR IMPACT TO PATIENT). PRODUCT PROBLEM(S): "LOW VACUUM" (ASPIRATION ISSUE). THE NURSE REPORTED LOW VACUUM. THE HANDPIECE WAS SWITCHED OUT SEVERAL TIMES WITHOUT A CHANGE IN VACUUM. THE SYSTEM WAS SWITCHED OUT AND THE CASE WAS COMPLETED. THE CASE WAS DELAYED 14-17 MINUTES. NO PATIENT INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK