BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM

    MDR report key: 2193482 · Received July 13, 2011

    Report

    Report Number
    2028159-2011-00806
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    June 10, 2011
    Report Date
    June 13, 2011
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CTR
    Product Code
    HQC
    PMA / PMN Number
    K021566
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP EXAMINED THE SYSTEM AND REPLACED THE IRRIGATION PRESSURE SENSOR (IPS) LOAD CELL AND SOLENOID RS. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. A ROOT CAUSE COULD NOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED A SYSTEM MESSAGE WAS DISPLAYED DURING A CATARACT PROCEDURE. AFTER A DELAY OF 30 MINUTES, THE SURGERY WAS COMPLETED WITH AN ALTERNATE SYSTEM. THERE WAS NO PT HARM REPORTED. SUBSEQUENTLY, SIX SURGERIES WERE CANCELED AS A RESULT OF THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1