BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S4-IR-ETL

    MDR report key: 5208784 · Received November 6, 2015

    Report

    Report Number
    3006695864-2015-00782
    Event Type
    Injury
    Date Received
    November 6, 2015
    Date of Event
    September 4, 2015
    Report Date
    November 6, 2015
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    LZS
    PMA / PMN Number
    P930016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: IN INITIAL REPORT THE WRONG PMA NUMBER WAS PROVIDED. THE CORRECT PMA NUMBER IS P930016.

    Additional Manufacturer Narrative · 1

    CORRECTION: IT WAS INCORRECTLY REPORTED THAT DATE OF EVENT WAS (B)(6) 2015. THE DATE OF EVENT WAS ONE IT WAS INCORRECTLY REPORTED THAT PATIENT HAD CUSTOM INTRALASE IN BOTH EYES ON (B)(6) 2015. THE SURGERY OCCURRED ON (B)(6) 2015.

    Additional Manufacturer Narrative · 1

    (B)(4). FIELD SERVICE SPECIALIST VISITED THE ACCOUNT AND CHECK THE EQUIPMENT. HE RECOMMENDED HVAC AIR FILTERS TO BE CHANGED, WIPE DOWN OPERATING ROOM AND VENTS. HE VERIFIED THAT THE SYSTEM WAS WITHIN THE PREVENTIVE MAINTENANCE (PM) WINDOW HOWEVER, HE DID PERFORM THE ANNUAL PM. HE FOUND THAT THE CHAIR CONTROLLER WAS DAMAGED AND REPLACED DURING THE PM WHEN CORDS RUNNING UNDER THE SYSTEM WERE MOVED, THEY UNPLUGGED POWER FROM THE PATIENT BED. APPLICATIONS SUPPORT MANAGER (ASM) CONTACTED THE ACCOUNT AND REPORTED THAT ALL OTHER PATIENTS FROM (B)(6) 2015 SURGICAL DAY WITHOUT CONCERN. NO INTRALASE SETTINGS HAVE BEEN ALTERED AND LAST SERVICED ON (B)(6) 2015. VISX LAST SERVICED ON (B)(6) 2015. SITE USES A STATIM AUTOCLAVE, SERVICED EVERY 6 MONTHS, LAST COMPLETED IN (B)(6) 2015. AUTOCLAVE IS DRAINED DAILY, SPORE TESTED WEEKLY AND PASSED, HEAT INDICATOR STRIPS UTILIZED AND PASSED EVERY CYCLE, WIPED DOWN WITH .99 ALCOHOL ROUTINELY FOLLOWED WITH WATER RINSE. RUBBER INSTRUMENT TRAY PLACED IN AUTOCLAVE IS QUESTIONABLE AS TO THE AGE. SITE USES 3 RE-USEABLE CANNULAS PER DAY AND ROTATES THEM THRU THE AUTOCLAVE. THE CANNULAS ARE CLEANED, RINSED AND FLUSHED WITH STERILE WATER, AIR PUSHED THRU THEM AND THEN AUTOCLAVED. THE CANNULA USED ON THIS PATIENT WAS NEW. SITE CLEANS INSTRUMENTS WITH UNIVERSAL CLEANER AND 2 RINSE CYCLES IN STERILE WATER. SITE USES 15CC BSS, STERILE BLUE DRAPES FOR SURGICAL TRAY, BECTON-DICKINSON ULTRASPEAR MEROCELS AND HAVE USED SAME BRAND FOR YEARS. ONLY THE SCRUB TECH WEARS POWDER FREE GLOVES, SELECT LATEX SURGICAL GLOVES. NO ENVIRONMENTAL CHANGES NOTED. ASM DISCUSSED POTENTIAL SOURCES OF CONCERN INCLUDING RUBBER INSTRUMENT TRAY WITHIN AUTOCLAVE, WIPING AUTOCLAVE CASSETTE WITH .99 ALCOHOL, AND USE OF RE-USEABLE CANNULAS. THE ACCOUNT SCHEDULED THE AUTOCLAVE COMPANY TO COME IN AND PERFORM 6 MONTH AUTOCLAVE SERVICING AND DISCUSS PROPER CLEANING AND MAINTENANCE PROTOCOL. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    SURGEON REPORTED PATIENT HAD CUSTOM INTRALASE IN BOTH EYES ON (B)(6) 2015 AND WAS THE 5TH PATIENT THAT MORNING. ONE DAY POSTOP SEEING 20/20 IN BOTH EYES AND NOTED DIFFUSE LAMELLAR KERATITIS (DLK) IN LARGE AREA OF LEFT EYE ONLY. SURGEON INCREASED DUREZOL 6 TIMES A DAY AND CONTINUE WITH VIGAMOX ALSO 4 TIMES A DAY. ONE WEEK POST OP PATIENT VISUAL ACUITY WAS 20/15 AND DLK WAS CLEAR. HE DISCONTINUED VIGAMOX AND DUREZOL. TWO WEEKS POST OP PATIENT VISUAL ACUITY WAS 20/25 RIGHT EYE AND 20/20 LEFT EYE. MANIFEST REFRACTION: RIGHT -0.25 SPH, LEFT PLANO +0.25 SPH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738918 S4-IR-ETL EXCIMER LASER LZS ABBOTT MEDICAL OPTICS 0030-4864

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention