BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM

    MDR report key: 2192991 · Received July 21, 2011

    Report

    Report Number
    2028159-2011-00837
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Report Date
    June 21, 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
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REPRESENTATIVE EXAMINED THE SYSTEM AND FOUND THE SYSTEM WOULD ONLY RECOGNIZE CERTAIN HANDPIECES. THE COMPANY REPRESENTATIVE REPLACED THE ULTRASONIC (U/S) CONTROLLER PRINTED CIRCUIT BOARD (PCB) AND THE U/S HANDPIECE CONTROLLER CABLE. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. ADDITIONAL PRODUCT INFORMATION IS PENDING. 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 CUSTOMER REPORTED THAT THE HANDPIECE WAS NOT WORKING CORRECTLY AND A SIGNIFICANT DELAY WAS EXPERIENCED DURING SURGERY. DESPITE REQUESTS FOR INFORMATION REGARDING THE IMPACT ON THE PATIENT, THE CUSTOMER DID NOT PROVIDE ANY ADDITIONAL INFORMATION.

    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 UNK