BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 2020555 · Received February 10, 2011

    Report

    Report Number
    2028159-2011-00077
    Event Type
    Malfunction
    Date Received
    February 10, 2011
    Date of Event
    January 10, 2011
    Report Date
    January 10, 2011
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K082845
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVAL: THE COMPANY REP EXAMINED THE SYS AND WAS UNABLE TO DUPLICATE THE REPORTED PROBLEM. THE SYS WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. ROOT CAUSE: A ROOT CAUSE HAS NOT BEEN IDENTIFIED. ACTIONS TAKEN: NO ADDITIONAL ACTION IS PLANNED AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED: THE SYS STOPPED RESPONDING DURING THE PROCEDURE. THE SYS WAS EXCHANGED TO COMPLETE THE SURGERY. NO INJURY OR HARM REPORTED. ADDITIONAL INFO WAS REQUESTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1