BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM

    MDR report key: 2241411 · Received August 18, 2011

    Report

    Report Number
    2028159-2011-00962
    Event Type
    Malfunction
    Date Received
    August 18, 2011
    Date of Event
    June 22, 2011
    Report Date
    July 19, 2011
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K021566
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    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. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED AFTER THE SURGEON ENTERED THE PATIENT'S EYE, THE "CHAMBER DROPPED". THE PHACO HANDPIECE WAS REMOVED FROM THE EYE, THE CASSETTE WAS REPLACED, AND THE PROCEDURE CONTINUED. AFTER THE SURGERY, A PUDDLE OF FLUID WAS NOTED UNDER THE SYSTEM. THERE WAS NO PATIENT IMPACT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 INFINITI BASIC PACK