BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 3851751 · Received April 22, 2014

    Report

    Report Number
    2028159-2014-00740
    Event Type
    Malfunction
    Date Received
    April 22, 2014
    Date of Event
    March 25, 2014
    Report Date
    March 25, 2014
    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
    MX
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE SERVICE REPORT INDICATES POOR ASPIRATION FROM THE SYSTEM. THE COMPANY REPRESENTATIVE EXAMINED THE SYSTEM. THERE WERE NO ISSUES FOUND WITH THE SYSTEM. THE SYSTEM FUNCTIONED OKAY. NO SERVICE TEST PROCEDURE (STP) WAS PERFORMED. THERE WAS NO SAMPLE RETURNED FOR EVALUATION AND NO ADDITIONAL INFO PROVIDED RELATED TO THIS EVENT. FOR THIS REASON, STEPS COULD NOT BE TAKEN TO REPLICATE OR CONFIRM THE REPORTED EVENT. A REVIEW OF COMPLAINTS FOR THE LAST 24 MONTHS DID INDICATE 2 RELATED REPORTS FOR THIS SYSTEM. THE ROOT CAUSE CANNOT BE DETERMINED CONCLUSIVELY. (B)(4).

    Description of Event or Problem · 1

    A DOCTOR REPORTED POOR ASPIRATION DURING A CATARACT PROCEDURE. THE CASE WAS COMPLETED WITH AN ALTERNATE SYSTEM. THERE WAS NO HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243743 INFINITI VISION SYSTEM OZIL PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER INFINITI OZIL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK