BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 1913692 · Received November 12, 2010

    Report

    Report Number
    2028159-2010-02212
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Date of Event
    October 14, 2010
    Report Date
    October 14, 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
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPANY SERVICE REP EXAMINED THE SYSTEM AND CONFIRMED THE REPORTED SYSTEM MESSAGE IN THE EVENT LOG. THE SOLENOID SPACERS WERE REPLACED AND THE SYSTEM SOFTWARE WAS UPGRADED. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECS. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THE UNIT WAS DOWN. THE CUSTOMER SERVICE REP REPORTED BECAUSE THE CUSTOMER HAD NOT RETURNED HIS CALL, A VISIT WAS MADE TO THE SITE. THE TECHNICIANS WERE CONTACTED AND REPORTED A SYSTEM MESSAGE HAD BEEN REC'D, WHICH WAS VERIFIED BY THE SERVICE REP IN THE EVENT LOG. ADDITIONAL INFO HAS BEEN REQUESTED.

    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