BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 2030886 · Received March 4, 2011

    Report

    Report Number
    2028159-2011-00194
    Event Type
    Malfunction
    Date Received
    March 4, 2011
    Report Date
    February 2, 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
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF COMPLAINTS FOR THE LAST 24 MONTHS DID NOT INDICATE ANY ADDITIONAL SIMILAR REPORTS FOR THIS SYSTEM. THE COMPANY SERVICE REPRESENTATIVE EXAMINED THE SYSTEM. THE IRRIGATION/ASPIRATION TIPS WERE FOUND TO BE CLOGGED. THE TIPS WERE CLEANED AND THE SITUATION WAS DISCUSSED WITH THE CUSTOMER. THE SYSTEM WAS THEN TESTED AND FOUND TO MEET SPECIFICATIONS. THE ROOT CAUSE OF THE REPORTED POOR VACUUM IN I/A MODE IS ATTRIBUTED TO CLOGGED I/A TIPS. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT SURGERY HAD BEGUN WHEN IT WAS NOTED THAT THE VACUUM WAS LESS THAN DESIRED IN THE IRRIGATION/ASPIRATION MODE. THE ASPIRATION DID NOT WORK WELL ENOUGH TO COMPLETE THE CASE IN A NORMAL FASHION. THERE WAS NO HARM OR INJURY TO THE PATIENT.

    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