BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 1791452 · Received August 6, 2010

    Report

    Report Number
    2028159-2010-01425
    Event Type
    Malfunction
    Date Received
    August 6, 2010
    Report Date
    July 8, 2010
    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
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPANY SERVICE REP EXAMINED THE SYSTEM. THE FLUIDICS MODULE SOLENOID SPACERS WERE REPLACED. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. A REVIEW OF COMPLAINTS FOR THE LAST 24 MONTHS INDICATED NO ADD'L, RELATED REPORTS FOR THIS SYSTEM. A REVIEW OF SERVICE REQUESTS FOR THE LAST 24 MONTHS INDICATED ONE ADDITIONAL, RELATED REPORT FOR THIS SYSTEM. THE ROOT CAUSE IS ATTRIBUTED TO DEGRADED FIELD REPLACEABLE SPACERS. AN INTERNAL INVESTIGATION HAS BEEN OPENED TO ADDRESS THE ISSUE REPORTED. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "NO PATIENT INVOLVEMENT" (NO PATIENT INVOLVEMENT). PRODUCT PROBLEM(S): "SYSTEM MESSAGE CODE." (DEVICE DISPLAYS ERROR MESSAGE); "SYSTEM SWITCHED OUT TO COMPLETE CASES." (NO CODE AVAILABLE). A NURSE REPORTED THE SYSTEM DISPLAYED AN ERROR MESSAGE DURING SET UP. A DIFFERENT MACHINE WAS USED TO COMPLETE THE CASES FOR THE DAY WITHOUT DELAY. THE PTS HAD NOT YET BEEN PREPPED WHEN THE SYSTEM WAS SWITCHED OUT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1