BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM

    MDR report key: 4253231 · Received November 13, 2014

    Report

    Report Number
    2028159-2014-02173
    Event Type
    Malfunction
    Date Received
    November 13, 2014
    Date of Event
    October 1, 2014
    Report Date
    October 17, 2014
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENER
    Product Code
    HQC
    PMA / PMN Number
    K021566
    Removal / Correction Number
    PENDING
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME THE RECALL NUMBER HAS NOT BEEN ISSUED. A SUPPLEMENTAL MDR WILL BE FILED WHEN THE RECALL NUMBER IS ISSUED. THE CUSTOMER'S COMPLAINT HISTORY WAS REVIEWED FOR THE PERIOD OF ONE YEAR, THIS IS ONE OF TWO 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. WHILE A SAMPLE WAS NOT RETURNED FOR THIS EVENT, SIMILAR COMPLAINT INVESTIGATIONS DETERMINED THAT DEBRIS WITHIN THE ASPIRATION TUBING RESULTED IN THE REPORTED EVENT. THE DEBRIS HAS BEEN IDENTIFIED AS A PIECE OF THE ASPIRATION TUBING WHICH WAS INADVERTENTLY INSERTED INTO THE ASPIRATION LINE DURING MANUFACTURING. THIS MANUFACTURING EVENT IS BELIEVED TO BE RELATED TO MISALIGNMENT OF THE TOOLING ON THE AUTOMATED PRODUCTION LINE. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT DURING THE PHACOEMULSIFICATION STEP OF A CATARACT PROCEDURE THE OCCLUSION BELL SOUNDED. THE OCCLUSION BELL WAS NOT CLEARED BY FLUSHING THE HANDPIECE, CHANGING THE TIP, OR CHANGING THE HANDPIECE. THEREFORE, THE CASSETTE WAS REPLACED AND THE SURGERY WAS ABLE TO BE COMPLETED. NO HARM TO THE PATIENT WAS REPORTED. A PRODUCT SAMPLE IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    733691 INFINITI VISION SYSTEM PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENER INFINITI NA

    Patients

    Seq Age Sex Outcome Treatment
    1 PAK, 0.9 TAPERED, ASPIRATION BYPASS SYS, 30 KELMAN