BEUDAMED
    FDA Adverse Event Other Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 2163702 · Received June 16, 2011

    Report

    Report Number
    2028159-2011-00668
    Event Type
    Other
    Date Received
    June 16, 2011
    Date of Event
    May 12, 2011
    Report Date
    May 16, 2011
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K082845
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP EXAMINED THE SYSTEM AND WAS ABLE TO DUPLICATE THE CUSTOMER REPORTED EVENT. THE CUSTOMER REQUESTED THE COMPANY REP TURN OFF VIT SETUP SCREEN TO PREVENT RECURRENCE OF THE EVENT. PREVENTIVE MAINTENANCE WAS PERFORMED. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. NO SAMPLE WAS RETURNED FOR EVAL AND NO ADDITIONAL INFO PROVIDED RELATED TO THIS EVENT. FOR THIS REASON, STEPS COULD NOT BE TAKEN TO REPLICATE THE REPORTED EVENT. THE ROOT CAUSE IS UNK AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    A HEALTHCARE PROFESSIONAL REPORTED WHILE THE SURGEON WAS IN THE VITRECTOMY MODE, A SYSTEM MESSAGE DISPLAYED AND THERE WAS NO IRRIGATION. AS A RESULT, THE PT'S ANTERIOR CHAMBER COLLAPSED. ADDITIONAL 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 Other