BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTURION VISION SYSTEM

    MDR report key: 7764843 · Received August 8, 2018

    Report

    Report Number
    2028159-2018-01666
    Event Type
    Malfunction
    Date Received
    August 8, 2018
    Date of Event
    July 12, 2018
    Report Date
    October 23, 2018
    Manufacturer
    ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K121555
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION PROVIDED. THE SYSTEM'S OPERATOR¿S MANUAL CONTAINS INSTRUCTIONS FOR PROPER PRIME AND SETUP. THE GRAPHICAL USER INTERFACE ALSO PROMPTS THE USER THROUGH ALL OF THE STEPS REQUIRED TO PRIME AND TUNE THE PHACO HANDPIECE APPROPRIATELY. THE OPERATORS MANUAL ALSO STATES THE FOLLOWING WARNING(S): ADJUSTING ASPIRATION RATES OR VACUUM LIMITS ABOVE THE PRESET VALUES, OR LOWERING THE IOP OR IV POLE BELOW THE PRESET VALUES, MAY CAUSE CHAMBER SHALLOWING OR COLLAPSE WHICH MAY RESULT IN PATIENT INJURY. ENSURE THAT APPROPRIATE SYSTEM PARAMETERS AND SYSTEM SETTINGS ARE SELECTED PRIOR TO STARTING THE PROCEDURE. PARAMETER AND SYSTEM SETTINGS INCLUDE, BUT ARE NOT LIMITED TO, ULTRASOUND MODE, ULTRASOUND POWER, VACUUM, ASPIRATION FLOW RATE, BOTTLE HEIGHT, IOP, ETC. IF STREAM OF FLUID IS WEAK OR ABSENT WHILE FILLING TEST CHAMBER, GOOD FLUIDICS RESPONSE WILL BE JEOPARDIZED. GOOD CLINICAL PRACTICE DICTATES THE TESTING FOR ADEQUATE IRRIGATION AND ASPIRATION FLOW PRIOR TO ENTERING THE EYE. ENSURE THAT THE TUBINGS ARE NOT OCCLUDED DURING ANY PHASE OF OPERATION. IF THE HANDPIECE TEST CHAMBER IS COLLAPSED AFTER TUNING, THERE IS A POTENTIAL OF LOW IRRIGATION FLOW THROUGH THE HANDPIECE AND MAY RESULT IN A FLUIDIC IMBALANCE. THIS, IN TURN, MAY CAUSE A SHALLOWING OR COLLAPSING OF THE ANTERIOR CHAMBER. GOOD CLINICAL PRACTICE DICTATES TESTING FOR ADEQUATE IRRIGATION, ASPIRATION FLOW, REFLUX, AND OPERATION AS APPLICABLE FOR EACH HANDPIECE PRIOR TO ENTERING EYE. THERE IS NO EVIDENCE THAT THE DESIGN OR MANUFACTURING OF THE SYSTEM CONTRIBUTED TO THE REPORTED EVENT. THE COMPANY SERVICE REPRESENTATIVE EXAMINED THE SYSTEM AND WAS UNABLE TO REPLICATE OR CONFIRM THE REPORTED EVENTS. AS A PREVENTIVE MEASURE (PM), THE ACTIVE IRRIGATION (AI) BAG PRESSURE SENSOR (BPS) WAS REPLACED. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. THE SYSTEM WAS MANUFACTURED ON AUGUST 10, 2016. BASED ON QA ASSESSMENT, THE PRODUCT MET SPECIFICATIONS AT THE TIME OF RELEASE. THE SYSTEM WAS FOUND TO MEET SPECIFICATIONS; THEREFORE, THE ROOT CAUSE OF THE REPORTED EVENTS CANNOT BE DETERMINED CONCLUSIVELY. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT DURING SURGERY, ULTRASONIC OSCILLATION FAILURE OCCURRED AND THE ANTERIOR CHAMBER WAS UNSTABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602870 CENTURION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other