BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 4240311 · Received October 29, 2014

    Report

    Report Number
    2028159-2014-02007
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    September 29, 2014
    Report Date
    September 30, 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
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S COMPLAINT HISTORY WAS REVIEWED FOR THE PERIOD OF ONE YEAR; THIS IS ONE OF THREE COMPLAINTS REPORTED FOR THIS ISSUE. THIS IS ONE OF FOUR COMPLAINTS FOR THE FINISH GOODS LOT FOR THIS ISSUE. THE ORDER WAS BUILT AND RELEASED PER SPECIFICATION. THE CUSTOMER DID NOT RETAIN A SAMPLE FOR THIS COMPLAINT REPORT; VISUAL INSPECTION OR FUNCTIONAL TESTING COULD NOT BE CONDUCTED. THE ROOT CAUSE OF THE CUSTOMER'S COMPLAINT IS NOT KNOWN. WITHOUT A SAMPLE, IT IS NOT POSSIBLE TO ISOLATE THE ROOT CAUSE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT DURING A CATARACT SURGERY, THE SURGEON NOTICED LOW ASPIRATION. A PLASTIC MATERIAL WAS FOUND TO BE OBSTRUCTING THE FLUIDICS MANAGEMENT SYSTEMS TUBING. THE ISSUE WAS RESOLVED THROUGH PRODUCT REPLACEMENT. THERE WAS NO REPORT OF HARM TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691296 INFINITI VISION SYSTEM OZIL PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER INFINITI OZIL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 TAPERED ASPIRATION BYPASS SYSTEM| 30 KELMAN PACK| MICRO SLEEVE| ULTRASOUND FLUIDICS MANAGEMENT SYSTEM -