BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM

    MDR report key: 4133005 · Received September 29, 2014

    Report

    Report Number
    2028159-2014-01789
    Event Type
    Malfunction
    Date Received
    September 29, 2014
    Date of Event
    January 1, 2014
    Report Date
    September 3, 2014
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K112425
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    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 INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A BIOMEDICAL ENGINEER REPORTED DURING IRRIGATION/ASPIRATION MODE OF AN INTRAOCULAR LENS IMPLANT PROCEDURE INTERMITTENT BUBBLES, SURGES AND LOW SUCTION WAS EXPERIENCED. THE SURGEON COMPLETED SURGERY WITH THE SAME SYSTEM AND CONSUMABLE PRODUCT. THERE WAS NO HARM TO THE PT. A SAMPLE IS NOT EXPECTED SINCE THE CONSUMABLE PRODUCT WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606483 INFINITI VISION SYSTEM PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER INFINITI V3.0 NA

    Patients

    Seq Age Sex Outcome Treatment
    1