BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CENTURION VISION SYSTEM

    MDR report key: 5656051 · Received May 16, 2016

    Report

    Report Number
    2028159-2016-02023
    Event Type
    Injury
    Date Received
    May 16, 2016
    Date of Event
    April 13, 2016
    Report Date
    August 23, 2016
    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
    CA
    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

    THE CLINICAL ANALYST HAS REVIEWED THIS FILE AND STATED THE FOLLOWING: ¿THE SURGEON REPORTED A PATIENT EXPERIENCED POST-OPERATIVE INFLAMMATION RESEMBLING TOXIC ANTERIOR SEGMENT SYNDROME (TASS) FOLLOWING A CATARACT EXTRACTION PROCEDURE. THE COMPANY SALES REPRESENTATIVE SENT THE DIRECTIONS FOR USE (DFU) FOR CLEANING THE ULTRAFLOW I/A HANDPIECE WHICH INCLUDES RECOMMENDATIONS THAT NO ENZYME SOLUTION SHOULD BE USED TO CLEAN THE I/A HANDPIECE. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE FACILITY CHANGED THEIR INTERNAL PROTOCOL FOR CLEANING THE IRRIGATION/ASPIRATION (I/A) HANDPIECES. THE FACILITY HAS HAD NO FURTHER CASES OF TASS SINCE. THE MOST COMMON CAUSES OF 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 (BSSS) 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 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 SYSTEM, PHACO HANDPIECE, OR I/A HANDPIECE CONTRIBUTED TO THE REPORTED EVENT.¿ THE OPHTHALMIC VISCOELASTIC DEVICE (OVD) WAS NOT RETURNED. THE LOT NUMBER WAS NOT PROVIDED. ALL BATCHES ARE RELEASED ACCORDING TO THE REQUIRED SPECIFICATIONS. A LOT NUMBER WOULD BE REQUIRED FOR REVIEW OF THE COMPLAINT HISTORY AND FURTHER EVALUATION. THE CHEMISTRY AND MICROBIOLOGY DATA MUST MEET PRODUCT REQUIREMENTS PRIOR TO RELEASE OF PRODUCT. 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. THE OPHTHALMIC VISCOELASTIC DEVICE (OVD) WAS NOT RETURNED. THE CONSUMABLE LOT NUMBER WAS NOT PROVIDED. ALL BATCHES ARE RELEASED ACCORDING TO THE REQUIRED SPECIFICATIONS. A LOT NUMBER WOULD BE REQUIRED FOR REVIEW OF THE COMPLAINT HISTORY AND FURTHER EVALUATION. THE CHEMISTRY AND MICROBIOLOGY DATA MUST MEET PRODUCT REQUIREMENTS PRIOR TO RELEASE OF PRODUCT. THE ROOT CAUSE CANNOT BE DETERMINED CONCLUSIVELY. (B)(4).

    Description of Event or Problem · 1

    A DOCTOR REPORTED A PATIENT EXPERIENCED POST OPERATIVE INFLAMMATION RESEMBLING TOXIC ANTERIOR SEGMENT SYNDROME (TASS) FOLLOWING A CATARACT EXTRACTION PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE SITE CHANGED THEIR INTERNAL PROTOCOL FOR CLEANING THE IRRIGATION/ASPIRATION HANDPIECES AND HAVE HAD NO CASES OF TASS SINCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311363 CENTURION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other