BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 1970090 · Received January 14, 2011

    Report

    Report Number
    2028159-2011-00033
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Report Date
    December 15, 2010
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVAL: A COMPANY REP EXAMINED THE SYSTEM AND WAS UNABLE TO REPLICATE THE REPORTED EVENT. THE US CONTROLLER PRINTED CIRCUIT BOARD (PCB) WAS REPLACED AS A DIAGNOSTIC MEASURE. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. THE US CONTROLLER PCB WILL BE RETURNED FOR IN HOUSE TESTING. AN INVESTIGATION IS IN PROCESS. ROOT CAUSE: A ROOT CAUSE HAS NOT BEEN IDENTIFIED. THE ROOT CAUSE WILL BE REASSESSED UPON COMPLETING THE INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    A HEALTHCARE PROFESSIONAL REPORTED, A SYSTEM WAS OPERATING INTERMITTENTLY DURING A PROCEDURE CAUSING A DELAY. PT STATUS IS UNK. ADD'L INFO HAS BEEN 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