BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 2223907 · Received August 18, 2011

    Report

    Report Number
    2028159-2011-00966
    Event Type
    Injury
    Date Received
    August 18, 2011
    Date of Event
    July 13, 2011
    Report Date
    July 19, 2011
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K082845
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT REQUEST A SERVICE REQUEST TO CHECK THE SYSTEM NOR DID THEY SEND IN SAMPLES FOR EVALUATION. FOUR LOT NUMBERS WERE SUPPLIED FOR BALANCED SALT SOLUTION (BSS) POTENTIALLY USED DURING THE CASE. REVIEW OF THE COMPLAINT HISTORY FOR EACH OF THE 4 LOTS, REVEAL THAT NO COMPLAINT OF THE SAME NATURE WAS REPORTED FOR ANY OF THE LOTS. THESE LOTS MET ALL RELEASE CRITERIA PRIOR TO PRODUCT RELEASE. THE ROOT CAUSE IS UNK AT THIS TIME. AN INTERNAL INVESTIGATION, "INVESTIGATION INTO INCREASED REPORTS OF TASS (TOXIC ANTERIOR SEGMENT SYNDROME)", CONCLUDED THERE IS NO EVIDENCE THAT TASS IS ASSOCIATED WITH THE USE OF AN ALCON PRODUCT. IN ADDITION, A TASS TASK FORCE, SPONSORED BY THE ASCRS AND UNDER THE LEADERSHIP OF DR (B)(6), MET ON AN ONGOING BASIS AND COMPILED DATA REGARDING THE INCREASED INCIDENCE OF TASS CASES. THE TASS TASK FORCE FINAL REPORT DATED (B)(4), 2006, FOUND NO CONCLUSIVE EPIDEMIOLOGIC DATA TO SUGGEST THAT ANY ONE PRODUCT WAS RESPONSIBLE FOR THE INCREASE IN TASS CASES THAT WERE REPORTED. CAREFUL ANALYSIS OF THE INFORMATION PROVIDED DID NOT REVEAL A SINGLE CAUSE OR POINT SOURCE RELATED TO THIS TASS OUTBREAK. THEIR INVESTIGATION FAILED TO IDENTIFY EVIDENCE SUPPORTING AN ASSOCIATION BETWEEN A SHARED PRODUCT AND THE CASES OF TASS REPORTED. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED POSSIBLE CASES OF TOXIC ANTERIOR SEGMENT SYNDROME (TASS). CULTURES WERE PERFORMED AND RESULTS WERE NEGATIVE. THE PT HAS SEEN A RETINAL SPECIALIST AND HAS RECEIVED VITREOUS TAP INJECTIONS. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THIS IS THE FIRST OF THREE REPORTS BEING FILED FOR THIS FACILITY.

    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 Required Intervention ULTRASONIC INFUSION PAK 0.9MM| DUOVISC| BALANCED SALINE SOLUTION (BSS)