BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 3070634 · Received April 17, 2013

    Report

    Report Number
    2028159-2013-00717
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Date of Event
    March 22, 2013
    Report Date
    March 22, 2013
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLES WERE RETURNED FOR EVALUATION. NO LOT NUMBER WAS IDENTIFIED WITH THIS COMPLAINT; THEREFORE, A LOT HISTORY REVIEW COULD NOT BE CONDUCTED. BECAUSE A SAMPLE WAS NOT RETURNED AND NO LOT INFORMATION WAS PROVIDED, THE ROOT CAUSE FOR THE COMPLAINT ISSUE CANNOT BE DETERMINED. THE O-RINGS NEED TO BE CHECKED FOR DAMAGE AND WEAR PRIOR TO EACH SETUP AS STATED IN THE DIRECTION FOR USE. THE REUSABLE HANDPIECE TIP SHOULD NOT HAVE BEEN USED IF AN O-RING WAS NOT PRESENT. THIS WILL RESULT IN A POOR VACUUM AS STATED IN THE COMPLAINT. ALL HANDPIECE TIPS ARE 100% VISUALLY INSPECTED BY TRAINED OPERATORS USING 15X MAGNIFICATION AND FLOW TESTED DURING MANUFACTURING. A HANDPIECE TIP WITH A MISSING O-RING WOULD HAVE BEEN FOUND DURING BOTH THE VISUAL AND FUNCTIONAL ASSESSMENT. NO ADDITIONAL ACTION IS REQUIRED AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    A BIOMEDICAL ENGINEER REPORTED POOR VACUUM DURING THE IRRIGATION/ASPIRATION (I/A) MODE OF A CATARACT EXTRACTION SURGERY. THE CUSTOMER CONTACTED TECHNICAL SERVICES AND DURING THE PHONE CALL DISCOVERED THE BLACK O-RING WAS MISSING FROM THE I/A TIP. ADDITIONAL INFORMATION WAS PROVIDED BY THE BIOMEDICAL ENGINEER INDICATING POOR SUCTION WAS NOTED DURING I/A MODE. THE DISPLAY READ "100 AND SHOULD HAVE READ 600". FOLLOWING A DELAY OF 30 MINUTES, THE CASE WAS COMPLETED USING THE LOWER SUCTION RATE WITH NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165083 INFINITI VISION SYSTEM OZIL PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER INFINITI OZIL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 I/A TIP CURVED 0.3MM ULTRAFLOW| I/A HANDPIECE BODY ULTRAFLOW