BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 1823627 · Received August 27, 2010

    Report

    Report Number
    2028159-2010-01582
    Event Type
    Malfunction
    Date Received
    August 27, 2010
    Date of Event
    July 28, 2010
    Report Date
    July 28, 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
    CO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY SERVICE REPRESENTATIVE EXAMINED THE SYSTEM AND NO PROBLEMS WERE FOUND WITH THE SYSTEM. THE COMPANY SERVICE REPRESENTATIVE TESTED THREE I/A SETS AND FOUND SEVEN NON-CONFORMING TIPS. THE COMPANY SERVICE REPRESENTATIVE RECOMMENDED THE NON-CONFIRMING TIPS BE REPLACED. THE CUSTOMER REPLACED THE I/A TIPS AND DISCARDED THE REPLACED TIPS. 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): "INTERMITTENT REFLUX" (REFLUX WITHIN DEVICE). THE CUSTOMER REPORTED INTERMITTENT REFLUX DURING THE I/A MODE. ADDITIONAL INFO RECEIVED FROM THE NURSE STATED FOUR CASES WERE CANCELED. TWO PTS WERE PREPPED BEFORE THE CANCELLATION. BOTH PTS WERE RECOVERED AND SENT HOME. 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