BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CENTURION VISION SYSTEM

    MDR report key: 6600470 · Received May 31, 2017

    Report

    Report Number
    2028159-2017-02277
    Event Type
    Injury
    Date Received
    May 31, 2017
    Date of Event
    April 14, 2017
    Report Date
    August 24, 2017
    Manufacturer
    ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K121555
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    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).

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED ADDITIONAL CASES OF ENDOPHTHALMITIS AND TOXIC ANTERIOR SEGMENT SYNDROME (TASS) SINCE NOVEMBER. THE CUSTOMER THINKS IT IS SOMETHING THAT THEY ARE DOING BUT WANTED TO MENTION IT SINCE THEY USE OUR PRODUCTS. THE CUSTOMER PROVIDED SPECIFIC EVENT DETAILS FOR THIS PATIENT FOR CATARACT EXTRACTION ON THE LEFT EYE (OS). THE PATIENT PRESENTED WITH BLURRED VISION, INCREASED INFLAMMATION ONE (1) DAY POST-OPERATIVE. THE PATIENT HAD CORNEAL EDEMA, ANTERIOR CHAMBER FIBRIN AND HYPOPYON. THE FACILITY ASSISTANT ADMINISTRATOR COMPLETED A QUESTIONNAIRE. THE PATIENT WAS A B)(6)YEAR OLD MALE. THE PATIENT WAS NOT HOSPITALIZED. THE PATIENT WAS ON PRE-OPERATIVE DROPS. ON THE DAY OF SURGERY THE PATIENT WAS GIVEN: DILATING DROPS, BETADINE, ANTI-INFLAMMATORY DROPS, ARTIFICIAL TEARS AND GLAUCOMA DROPS. POST-OPERATIVE ANTI-INFLAMMATORY DROPS WERE GIVEN. THE UNPLANNED SURGICAL INTERVENTION WAS REQUIRED TO TREAT THE EVENT WAS AN ANTERIOR CHAMBER TAP WITH INJECTION OF 0.1CC FORTIFIED ANTI-BIOTIC WAS GIVEN OD. IN THE SURGEON¿S OPINION IT IS UNKNOWN WHICH DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE PATIENT HAS A HISTORY OF CATARACTS (BOTH EYES), DRY EYES BOTH EYES, HYPERLIPIDEMIA, AND HYPERTENSION. INTRACAMERAL LIDOCAINE WAS USED. THE PATIENT WAS PREPPED WITH BETADINE. THE INCISION WAS A TEMPORAL CLEAR CORNEAL INCISION AT 2.2MM. THERE WAS ONE SIDE PORT. THE WOUND INTEGRITY WAS INTACT WITH NEGATIVE SEIDEL. THE OVD WAS REMOVED DURING I/A (IRRIGATION AND ASPIRATION). THE IRRIGATING SOLUTION WAS BALANCED SALT SOLUTION (BSS) WITH NO ADDITIVE. THE INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE BAG. THE DURATION OF SURGERY WAS FIFTEEN (15) MINUTES. THIS WAS THE FOURTH (4) CASE OF THE DAY. THERE WAS NO SEQUENCE OF PATIENT CASES THAT DEVELOPED TOXIC ANTERIOR SEGMENT SYNDROME (TASS). THE AUTOCLAVE WAS LAST SERVICED IN NOVEMBER 2016. DISTILLED WATER IS USED IN THE AUTOCLAVE. THE STERILIZATION VALIDATION IS COMPLETED DAILY. THE INSTRUMENTS ARE STERILIZED AT 270 DEGREE/27.1 PSI FOR FOUR MINUTES (4) IN A PRE-VAC UNWRAPPED CYCLE. THE DRY TIME IS TWENTY (20) MINUTES. AN ULTRASONIC CLEANER IS USED TO CLEAN THE CANNULAS. THE SOLUTION USED IS (B)(4), WHICH IS CHANGED EVERY DAY. THE ULTRASONIC CLEANER IS CLEANED EVERY MORNING. THE INSTRUMENTS ARE MANUALLY CLEANED WITH A SOFT BRUSH OR INSTRUMENT WIPE TO ENSURE RESIDUE IS REMOVED. THE INSTRUMENTS ARE NOT EXPOSED TO A WASHER STERILIZER, ENZYMATIC CLEANER, OR DETERGENTS. THE TIPS AND SLEEVES ARE REMOVED BEFORE STERILIZING. THE REUSABLE CANNULAS AND HANDPIECES ARE IRRIGATED AFTER USE IN SURGERY, DURING CLEANING, AND PRIOR TO STERILIZATION. THE CUSTOMER USES 120 CC OF WATER TO FLUSH THE CANNULAS AND HANDPIECES. THE INSTRUMENTS SIT IN THE WORK ROOM FIVE (5) MINUTES OR LESS BEFORE CLEANING AND STERILIZATION. NO SINGLE USE PRODUCTS ARE RE-USED. THE HANDPIECE AND SYSTEM HAVE BEEN USED SINCE THE EVENT WITH NO FURTHER PROBLEMS NOTED. THE FACILITY ASSISTANT ADMINISTRATOR NOTED THEY HAVE SEVEN (7) HANDPIECES, WITH SIX (6) HANDPIECES THAT STAY WITH THE TRAY OF INSTRUMENTS. THE OUTCOME OF THE EVENT WAS NOTED AS NOT RESOLVED WITH TREATMENT CONTINUING WITH A RETINAL SPECIALIST. THE MOST COMMON CAUSES OF TOXIC ANTERIOR SEGMENT SYNDROME (TASS) ARE IDENTIFIED AS FOLLOWS IN ORDER OF PREVALENCE: INADEQUATE FLUSHING OF PHACO, IRRIGATION/ASPIRATION HANDPIECES AND CANNULATED EQUIPMENT, USE OF ENZYMATIC CLEANERS AND DETERGENTS, USE OF REUSABLE CANNULAS, INADEQUATE CLEANING OF INSTRUMENTS, USE OF PRESERVED EPINEPHRINE, REUSE OF SINGLE USE DEVICES, USE OF TAP WATER WITH NO STERILE WATER FINAL RINSE, INADEQUATE PERSONNEL OR TRAYS TO ALLOW PROPER PREPARATION OF INSTRUMENTS, NO IMMEDIATE CLEANING ALLOWING OPHTHALMIC VISCOELASTIC DEVICE (OVD) AND SURGICAL SOLUTIONS TO DRY ON INSTRUMENTS, USE OF PRESERVED MEDICINES IN THE EYE, REUSE OF TUBING FOR FLUSHING, LATEX BULBS FOR IRRIGATION, NOT TRAINING, NO TERMINAL STERILIZATION, INSTRUMENTS STORED ON TOWELS, TOUCHING OF IOL OR PATIENT CONTACT AREAS OF INSTRUMENTS WITH GLOVED HANDS, OFF-LABEL USE OF LIDOCAINE GEL, POOR INSTRUMENT MAINTENANCE, AUTOCLAVE RESIDUE, RUST, PARTICULATES, LINT, USE OF POWDERED GLOVES, ADDITIVES ADDED TO BALANCED SALT SOLUTION AGAINST DIRECTIONS FOR USE (DFU) , IMPROPER USE OF PREP SOLUTIONS, DETERGENTS AND CLEANERS, FAILURE TO FOLLOW MANUFACTURER¿S DIRECTIONS FOR USE, INCLUDING NO AIR FLUSH, USE OF UNAPPROVED ENZYMATIC CLEANERS, USE OF POSTOPERATIVE OINTMENT IN CLEAR CORNEAL CASES, POVIDONE-IODINE PLACED IN THE EYE AT THE END OF PROCEDURES, INCORRECT CONCENTRATION OF DETERGENTS AND ENZYMATIC CLEANERS. THE SYSTEM IS A CLOSED SYSTEM. IT IS OPERATED WITH A STERILE SINGLE USE CONSUMABLE CASSETTE WHICH IS DESIGNED TO ISOLATE THE PATIENT FLUID PATH FROM THE CONSOLE ITSELF. ANY REUSABLE SURGICAL INSTRUMENTATION (PHACO HANDPIECE) THAT WOULD COME INTO CONTACT WITH THE PATIENT WOULD BE AUTOCLAVED BY THE USER PRIOR TO SURGERY, PER STANDARD INDUSTRY PRACTICES AND THE PRODUCT DIRECTIONS FOR USE (DFU). THE PHACO HANDPIECE IS A REUSABLE DEVICE THAT MUST BE REPROCESSED PER THE PRODUCT DFU. THERE IS NO EVIDENCE THAT THE DESIGN OR PERFORMANCE OF THE EQUIPMENT CAUSED OR CONTRIBUTED TO THIS REPORTED EVENT OF ENDOPHTHALMITIS. THE PHACO HANDPIECE DIRECTIONS FOR USE (DFU) RECOMMEND PUSHING A MINIMUM OF 120CC OF ROOM TEMPERATURE STERILE DEIONIZED WATER THROUGH BOTH THE IRRIGATION AND ASPIRATION PATHS, AND A STERILIZATION PRE-VAC WRAPPED CYCLE FOR A MINIMUM EXPOSURE TIME OF THREE MINUTES (3) AND A MINIMUM DRY TIME OF SIXTEEN (16) MINUTES. NO FURTHER INFORMATION WAS ABLE TO BE OBTAINED FROM THIS CUSTOMER. WITH NO ADDITIONAL, RELATED INFORMATION PROVIDED, THE CUSTOMERS REPORTED EVENT WAS NOT ABLE TO BE CONFIRMED. ALL COMPOUNDING, PREPROCESSING, FILLING AND PACKAGING MBRS ARE SUBJECTED TO 2 INDEPENDENT REVIEWS. A MINIMUM SINGLE NORMAL LEVEL L INSPECTION IS PERFORMED FOR EVERY LOT MANUFACTURED. THIS PRODUCT IS TERMINALLY STERILIZED AND ALL STERILIZATION CYCLES ARE REVIEWED BEFORE PRODUCT IS RELEASED. PRIMARY INCOMING COMPONENT BAGS ARE REVIEWED BY QA BEFORE RELEASE TO PRODUCTION. LABELING ASSOCIATED WITH BSS REQUIRES THE USER TO NOT USE UNLESS OUTER OVER WRAP IS INTACT, PRODUCT IS CLEAR, SEAL IS INTACT AND BAG IS UNDAMAGED. ADDITIONALLY, IT STATES UNDER WARNINGS: THE USE OF ADDITIVES WITH THIS SOLUTION MAY CAUSE CORNEAL DECOMPENSATION. NO LOT CODE WAS REPORTED THEREFORE LOT SPECIFIC EVALUATION IS NOT POSSIBLE. ALL LOT DOCUMENTATION IS REVIEWED PRIOR TO DISPOSITION TO ENSURE THAT THE PRODUCT MEETS SPECIFICATIONS. THE ROOT CAUSE CANNOT BE DETERMINED CONCLUSIVELY. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT ON POST OPERATIVE VISIT AFTER CATARACT EXTRACTION WITH INTRAOCULAR LENS IMPLANT PROCEDURE, THE PATIENT PRESENTED WITH INCREASED INFLAMMATION, CORNEAL EDEMA, HYPOPYON AND BLURRED VISION IN THE LEFT EYE. ENDOPHTHALMITIS/TOXIC ANTERIOR SEGMENT SYNDROME (TASS) IS SUSPECTED. THE PATIENT WAS REFERRED TO RETINAL SPECIALIST FOR AN AQUEOUS AND VITREOUS TAP. INTRAVITREAL INJECTIONS OF ANTIBIOTICS WERE ADMINISTERED. THE PATIENT'S SYMPTOMS ARE CONTINUING. THIS IS THE ONE OF SEVERAL REPORTS FOR THIS FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383003 CENTURION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention BESIVANCE| BETADINE| BSS BAG 500ML| COMBIGAN| ILEVERO| LIDOCAINE| LOTEMAX GEL| PHENYLEPHERINE| PROVISC| SYSTANE| TETRACAINE| TRAVATAN Z| TROPICAMIDE| UNSPECIFIED CANNULAS| UNSPECIFIED HANDPIECE, ITC| VISCOAT