BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 1905581 · Received November 19, 2010

    Report

    Report Number
    2028159-2010-02222
    Event Type
    Injury
    Date Received
    November 19, 2010
    Date of Event
    October 26, 2010
    Report Date
    October 26, 2010
    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
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY SERVICE REPRESENTATIVE EXAMINED THE SYSTEM AND COULD NOT DUPLICATE THE PROBLEMS REPORTED. THE VACUUM AND FLOW CHECKS WERE COMPLETED WITH THE CUSTOMER'S CASSETTE AND A TEST CASSETTE. NO PROBLEMS WERE FOUND. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. (B)(4).

    Description of Event or Problem · 1

    THE SURGEON REPORTED THE SYSTEM WAS UNABLE TO ACHIEVE THE REQUIRED VACUUM LEVELS. THE HANDPIECE AND THE PHACO TIP WERE CHANGED. THE VACUUM PROBLEM DID NOT CLEAR. THE SURGEON CHANGED THE PHACO MODE FROM TORSIONAL TO ULTRASONIC. THE CASSETTE AND THE HANDPIECE WERE SUCCESSFULLY PRIMED AND TUNED. THE MAXIMUM VACUUM OF 700 MMHG WAS OBSERVED. THE VACUUM CHECK WAS ALSO PERFORMED AFTER CONNECTING THE ULTRASONIC HANDPIECE. THE CASSETTE PASSED THE TEST. THE VACUUM CHECK FAILED WHEN THE ULTRAFLOW I/A HANDPIECE WAS CONNECTED. THE I/A HANDPIECE WAS REPLACED AND THE VACUUM CHECK PASSED. THE SURGEON ATTEMPTED TO RESUME THE SURGICAL PROCEDURE. HOWEVER, ONCE THE SURGEON WAS WORKING IN THE PT'S EYE, THERE WAS STILL NO VACUUM. THE SURGERY WAS ABORTED. ADDITIONAL INFORMATION RECEIVED FROM THE COMPANY SERVICE REPRESENTATIVE STATED THE SURGEON REPORTED VACUUM ISSUES AND COLLAPSES. THE SURGEON PROCEEDED WITH THE SURGERY THAT WAS ABORTED EARLIER IN THE DAY. THE CASE WAS COMPLETED. THE COMPANY SERVICE REPRESENTATIVE OBSERVED SURGERY AND NOTED THE BOTTLE HEIGHT WAS A LITTLE TOO LOW. THE COMPANY SERVICE REPRESENTATIVE RECOMMENDED THE BOTTLE BE RAISED. A SECOND SURGEON COMPLETED SEVEN SURGERIES FOLLOWING THE FIRST SURGERY. THERE WERE NO FURTHER PROBLEMS REPORTED. THE SCRUB NURSES WHO USUALLY WORK WITH BOTH SURGEONS WERE NOT WORKING WHEN INCIDENT OCCURRED. NO PT INJURY WAS REPORTED.

    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 Required Intervention