BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM

    MDR report key: 2030948 · Received March 4, 2011

    Report

    Report Number
    2028159-2011-00212
    Event Type
    Malfunction
    Date Received
    March 4, 2011
    Date of Event
    February 8, 2011
    Report Date
    February 11, 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
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS IN PROGRESS. A SAMPLE WAS NOT RECEIVED FOR EVALUATION. A ROOT CAUSE HAS NOT BEEN IDENTIFIED. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THE IRRIGATION TUBING WAS DISCONNECTED, AT THE LEVEL OF THE WHITE LUER, DURING A PROCEDURE. THERE WAS NO INJURY TO THE PATIENT. THE CASSETTE WAS EXCHANGED TO COMPLETE THE SURGERY.

    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