BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM

    MDR report key: 4253226 · Received November 13, 2014

    Report

    Report Number
    2028159-2014-02174
    Event Type
    Malfunction
    Date Received
    November 13, 2014
    Date of Event
    October 16, 2014
    Report Date
    October 17, 2014
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    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

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. AT THE TIME, RECALL NUMBER HAS NOT BEEN ISSUED. A SUPPLEMENTAL MDR WILL BE FILED WHEN THE RECALL NUMBER IS ISSUED. (B)(4).

    Description of Event or Problem · 1

    A SURGICAL TECHNICIAN REPORTED THAT THE OCCLUSION BELL WENT OFF EXCESSIVELY DURING TWO CATARACT PROCEDURES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    733161 INFINITI VISION SYSTEM PHACOFRAGMENTTION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER INFINITI NA

    Patients

    Seq Age Sex Outcome Treatment
    1 ULTRASOUND FMS 0.9 MM TAPERED, ASPIRATION BYPASS| SYSTEM, 30K PACK