BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITI VISION SYSTEM

    MDR report key: 7066386 · Received November 29, 2017

    Report

    Report Number
    2028159-2017-04409
    Event Type
    Injury
    Date Received
    November 29, 2017
    Report Date
    February 1, 2018
    Manufacturer
    ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K120912
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    HEALTH PROFESSIONAL

    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

    A CUSTOMER REPORTED THAT CASES OF INFLAMMATION AND FIBRIN ARE INCREASING. PATIENTS ARE SHOWING THE INFLAMMATION THE DAY AFTER SURGERY. ADDITIONAL INFORMATION RECEIVED NOTED FOR THE LAST TWO MONTHS SOME PATIENTS HAVE BEEN SHOWING LEVELS OF INFLAMMATION DISPROPORTIONATE TO THE NON-COMPLEXITY OF THEIR CATARACT SURGERIES. ALL CASE WERE SHORT SURGERIES, STANDARD CATARACTS OF MEDIUM OR LOW HARDNESS WITH LOW PHACOEMULSIFICATION TIMES. THE PATIENTS PRESENTED THE FOLLOWING DAY WITH HIGH CELLULARITY IN THE ANTERIOR CHAMBER, FIBRIN AND NON-INFECTIOUS HYPOPYON. THIS REQUIRED ADMINISTRATION OF ANTI-INFLAMMATORY MEDICATIONS BY SUB-TENONS INJECTION TO CONTROL THE INFLAMMATION. THE SURGEON NOTED: "WE CONTINUE TO MAKE NUMEROUS CHECKS ON BOTH PHACOS AND ENVIRONMENT, STERILIZATION PROCEDURES, MEDICATION, ETC. SO FAR WE HAVE NOT BEEN ABLE TO FIND A REPETITION OF THE FACTORS IN THE PATIENTS IN WHICH THIS COMPLICATION HAS ARISEN. IN MANY, DIFFERENT EQUIPMENT, HANDLES, LOT PACKAGES, ETC. WERE USED AND NOT YET THE CAUSE HAS BEEN LOCATED. THE INFORMATION IS COLLECTING, SO FOR NOW I CANNOT GET IT TO YOU." FORTUNATELY, ALL THE PATIENTS HAVE BEEN EVOLVING SATISFACTORILY WITH THE TREATMENT. 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 ALCON PHACOEMULSIFICATION SYSTEMS ARE CLOSED SYSTEMS. THEY ARE OPERATED WITH A STERILE SINGLE USE CONSUMABLE CASSETTE WHICH IS DESIGNED TO ISOLATE THE PATIENT FLUID PATH FROM THE CONSOLE ITSELF. ANY SURGICAL INSTRUMENTATION THAT WOULD COME INTO CONTACT WITH THE PATIENT WOULD BE CLEANED AND AUTOCLAVED BY THE USER PRIOR TO SURGERY, PER STANDARD INDUSTRY PRACTICES AND COMPANY DIRECTIONS FOR USE (DFU). THE PROPER CLEANING AND STERILIZATION OF OPHTHALMIC SURGICAL INSTRUMENTS CAN HELP PREVENT THE OCCURRENCE OF TASS. THESE FINDINGS CONTINUE TO VALIDATE THE NEED TO FOLLOW THE RECOMMENDATIONS DETAILED IN THE DFUS, AORN RECOMMENDED PRACTICES, AND THE ASCRS TASS TASK FORCE GUIDANCE DOCUMENT. THERE IS NO EVIDENCE THAT THE DESIGN OR MANUFACTURING OF THE (B)(4) SYSTEM OR PHACO HANDPIECE CONTRIBUTED TO THE REPORTED EVENT. WITH NO ADDITIONAL, RELATED INFORMATION PROVIDED AND NO SAMPLE RETURNED, THE CUSTOMER REPORTED EVENT WAS NOT ABLE TO BE CONFIRMED. THE SYSTEM WAS MANUFACTURED ON DECEMBER 12, 2005. BASED ON QA ASSESSMENT, THE PRODUCT MET SPECIFICATIONS AT THE TIME OF RELEASE. THE ROOT CAUSE CANNOT BE DETERMINED CONCLUSIVELY. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT CASES OF INFLAMMATION AND FIBRIN ARE INCREASING. PATIENTS ARE SHOWING THE INFLAMMATION THE DAY AFTER SURGERY. SERVICE WAS PERFORMED ON THE SYSTEM. ADDITIONAL INFORMATION HAS BEEN RECEIVED INDICATING FOR THE LAST TWO MONTHS, SOME PATIENTS HAVE BEEN SHOWING LEVELS OF INFLAMMATION DISPROPORTIONATE TO THE NON COMPLEXITY OF THEIR CATARACT SURGERIES. ALL CASE WERE SHORT SURGERIES, STANDARD CATARACTS OF MEDIUM OR LOW HARDNESS AND LOW PHACOEMULSIFICATION TIMES. PATIENTS PRESENTED THE FOLLOWING DAY WITH HIGH CELLULARITY IN THE ANTERIOR CHAMBER, FIBRIN AND NON-INFECTIOUS HYPOPYON. THIS REQUIRED ADMINISTRATION OF ANTI-INFLAMMATORY MEDICATIONS SUPERIOR TO THE USUAL AND BY INFREQUENT ROUTES SUCH AS SUB-TENONS IN ORDER TO CONTROL THE INFLAMMATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    846307 INFINITI VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention OZIL TORSIONAL PHACO HANDPIECE