BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 1840051 · Received September 15, 2010

    Report

    Report Number
    2028159-2010-01731
    Event Type
    Malfunction
    Date Received
    September 15, 2010
    Date of Event
    August 16, 2010
    Report Date
    August 16, 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
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY SERVICE REP EXAMINED THE SYSTEM AND COULD NOT DUPLICATE THE PROBLEM REPORTED. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "NO PT INJURY REPORTED" (NO CONSEQUENCES OR IMPACT TO PT). PRODUCT PROBLEM(S): "HANDPIECE NOT RECOGNIZED" (DEVICE DISPLAYS ERROR MESSAGE). THE CUSTOMER REPORTED THE HANDPIECE WAS NOT RECOGNIZED BY THE SYSTEM. THE SYSTEM WAS SWITCHED OUT AND THE HANDPIECE PRIMED AND TUNED. THE CASE WAS COMPLETED AS PLANNED. NO PT INJURY WAS REPORTED.

    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 UNK