BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 2043318 · Received February 25, 2011

    Report

    Report Number
    2028159-2011-00185
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    January 20, 2011
    Report Date
    January 26, 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
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPANY REPRESENTATIVE EXAMINED THE SYSTEM AND WAS UNABLE TO REPLICATE THE REPORTED ISSUE. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. A ROOT CAUSE HAS NOT BEEN IDENTIFIED. (B)(4).

    Description of Event or Problem · 1

    A SCRUB TECH REPORTED THAT THERE WAS POOR VACUUM DURING THE IRRIGATION/ASPIRATION (I&A) PORTION OF THE CATARACT SURGERY. THE CASE WAS COMPLETED BY EXCHANGING THE SYSTEM. THE CASE WAS COMPLETED AFTER A DELAY OF ABOUT FIVE MINUTES. NO HARM TO THE PATIENT WAS REPORTED. ADDITIONAL INFORMATION 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 UNK