BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM

    MDR report key: 2161124 · Received June 17, 2011

    Report

    Report Number
    2028159-2011-00677
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 17, 2011
    Report Date
    May 18, 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 Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO SAMPLE RETURNED FOR EVALUATION AND NO ADDITIONAL INFORMATION PROVIDED RELATED TO THIS EVENT. FOR THIS REASON, STEPS COULD NOT BE TAKEN TO REPLICATE OR CONFIRM THE REPORTED EVENT AND THE ROOT CAUSE IS THEREFORE, UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT WHILE TRYING TO CONNECT THE VITRECTOME, FOLLOWING THE STEPS AS INDICATED ON THE SCREEN, THE VITRECTOME WOULD CUT BUT THE ASPIRATION WOULD NOT WORK PROPERLY AND THE IRRIGATION WOULD STOP CONTINUOUSLY. IT WAS ALSO REPORTED THAT THE BLUE ASPIRATION TUBING WAS DIFFICULT TO REMOVE FROM THE VITRECTOME AFTER USE. ADDITIONAL INFORMATION WAS RECEIVED FROM A COMPANY SALES REPRESENTATIVE INDICATING THE SURGERY WAS COMPLETED BY USING A NEW VITRECTOME. 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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1