BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM

    MDR report key: 1872937 · Received October 1, 2010

    Report

    Report Number
    2028159-2010-01869
    Event Type
    Malfunction
    Date Received
    October 1, 2010
    Date of Event
    April 14, 2010
    Report Date
    September 1, 2010
    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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER DID NOT RETURN A SAMPLE, SO A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. A REVIEW OF THE COMPLAINT DATABASE SHOWED NO OTHER COMPLAINTS OF THIS NATURE REPORTED FOR THIS FACILITY FOR THE PAST YEAR. (B)(4).

    Description of Event or Problem · 1

    RECEIVED A VOLUNTARY MEDWATCH REPORT FROM THE USER FACILITY. A QUALITY IMPROVEMENT ASSISTANT REPORTS DURING EXTRACAPSULAR CATARACT EXTRACTION THE FLUIDICS MANAGEMENT SYSTEM (FMS) FAILED. ANOTHER FMS WAS OPENED AND SURGERY WAS COMPLETED WITHOUT FURTHER OCCURRENCE. THERE WAS NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFINITI VISION SYSTEM PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER INFINITI 989030H

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR