BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 2081348 · Received April 22, 2011

    Report

    Report Number
    2028159-2011-00438
    Event Type
    Malfunction
    Date Received
    April 22, 2011
    Report Date
    March 23, 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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP EXAMINED THE SYSTEM AND CONFIRMED THE SYSTEM MESSAGE (SM) OCCURRED AT STARTUP. THE VALVE SOLENOID SPACERS WERE REPLACED AND DISPOSED OF. THE SYSTEM WAS THEN TESTED AND MET PRODUCT SPECS. A REVIEW OF COMPLAINTS FOR THE LAST 24 MONTHS DID NOT INDICATE ANY ADD'L SIMILAR REPORTS FOR THIS SYSTEM. ALTHOUGH NO SAMPLE WAS RETURNED FOR EVAL, THE ROOT CAUSE FOR THE REPORTED ISSUE IS ATTRIBUTED TO NON-CONFORMING VALVE SOLENOID SPACERS ON THE FLUIDICS MODULE. AN INTERNAL INVESTIGATION WAS OPENED TO ADDRESS EVENTS RELATED TO SYSTEM MESSAGES ASSOCIATED WITH THE VALVE SOLENOID SPACERS. THE RISK MGMT REPORT (RMR) FOR THE INFINITI SYSTEM ADDRESSES BOTH IRRIGATION AND VENT VALVES FAILURES AS EXISTING POTENTIAL HAZARDS/HARMS. THE INFINITI SOFTWARE CHECKS FOR IRRIGATION/VENT VALVE OPERATION AND REPORTS FAILURES AS ERROR CODES WHICH INSTRUCT USER TO TAKE IMMEDIATE ACTION. THESE FAILURES ARE ADEQUATELY MITIGATED DURING PRIMING AND DURING A PROCEDURE. ALCON WILL CONTINUE TO MONITOR DATA FOR EVIDENCE OF ADVERSE TRENDING AND TAKE FURTHER ACTION, AS APPROPRIATE. (B)(4).

    Description of Event or Problem · 1

    A BIOMEDICAL ENGINEER REPORTED THAT THE SYSTEM SHUT ITSELF DOWN. ADD'L INFO RECEIVED FROM ANOTHER HEALTHCARE PROFESSIONAL AT THE SITE INDICATED THAT THE SYSTEM SHUT DOWN DURING SURGERY. THEY DID NOT RESTART THE SYSTEM, BUT THEY QUICKLY EXCHANGED THE SYSTEM AND FINISHED THE CASE WITHOUT SIGNIFICANT DELAY AND NO CLINICAL IMPACT OR HARM TO THE PT.

    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