BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 2912183 · Received January 11, 2013

    Report

    Report Number
    3006695864-2013-00005
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    December 7, 2012
    Report Date
    December 12, 2012
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EQUIPMENT WAS EVALUATED BY A FIELD SERVICE ENGINEER (FSE) ON (B)(4) 2012, FOR A SYSTEM CHECKOUT. FSE GELLED THE LASER AND VERIFIED PROPER OPERATION. SYSTEM WAS TESTED AND MEETS AMO SPECIFICATIONS. ON (B)(6) 2012, CLINICAL DEVELOPMENT MANAGER (CDM) WAS ONSITE DUE TO THE REPORT OF DLK/HAZE. CDM NOTED THAT NO ONE IN THE OPERATING ROOM WEARS GLOVES; BOTH THE DOCTOR AND THE TECH USE SANITIZING FOAM TO CLEAN THEIR HANDS PRIOR TO EACH PROCEDURE (ALCARE FOAMED ANTISEPTIC HANDRUB). THE DOCTOR MARKS THE CENTER OF THE PUPIL WITH INKED OZ MARKER (VISCOT MINI PRE-SURGERY SKIN MARKERS), AND CREATES THE FLAP. HE THEN IMMEDIATELY LIFTS APPROXIMATELY 1/3 OF IT UNDER THE EXCIMER TO ALLOW THE GAS TO VENT. ONCE BOTH FLAPS ARE CREATED, HE INSERTS A SPECULUM, LIFTS THE BALANCE OF THE FLAP, AND APPLIES THE EXCIMER TREATMENT. THE FLAP IS THEN REPLACED, IRRIGATED, AND SMOOTHED OUT WITH A JOHNSTON FLAP APPLINATOR AND A WECK-CEL SPONGE. THE DOCTOR USES A BANDAGE CONTACT LENS AND PUNCTUAL PLUG ON EVERY PATIENT. CDM OBSERVED EIGHT PROCEDURES. THE TEMPERATURE WAS 73.8 AND THE HUMIDITY WAS 20%. THE INSTRUMENTS ARE CLEANED IN ENDOZIME AND RINSED IN TWO SEPARATE BOWLS OF DISTILLED WATER. THE AUTOCLAVES USE DISTILLED WATER AND ARE DRAINED WEEKLY. THE FREQUENTLY USED AREAS IN THE OPERATING ROOM ARE WIPED DOWN WITH A SANI-CLOTH PLUS WIPE BETWEEN EACH CASE. THE SITE HAS ALREADY TAKEN SOME PRECAUTIONS TO TROUBLESHOOT THIS PROBLEM, WHICH INCLUDE REMOVING BETADINE FROM THEIR PREP ROUTINE, CHANGING FROM ONE LARGE BALANCED SALT SOLUTION (BSS) BOTTLES, TO INDIVIDUAL BOTTLES, CHANGING ANTIBIOTICS, AND INCREASING FLAP THICKNESS FROM 90 TO 100 MICRONS. CDM RECOMMENDATIONS AND ACTIONS INCLUDED REPLACING THE FILTERS ON THE VENTILATION SYSTEM (THEY HAVE NOT BEEN CHANGED FOR FOUR TO SIX MONTHS). USE A "LENS DUST BLOWER" INSTEAD OF CANNED AIR TO CLEAR DEBRIS FROM THE INTRALASE CONE. CDM ALSO REMINDED DR (B)(6) THAT OUR RECOMMENDED FLAP THICKNESS IS BETWEEN 110 AND 120 MICRONS. CDM SPREAD OUT THE SPOT AND LAYER CONFIGURATION IN THE SIDE CUT FROM 3/3 TO 5/4, AND DECREASED THE ENERGY FROM 1.00 TO 0.80. . PATIENT #1 UCVA: 20/25, PATIENT #2 UCVA: UNKNOWN, PATIENT #3 UCVA: UNKNOWN, PATIENT #4 UCVA: UNKNOWN, PATIENT #5 UCVA: UNKNOWN.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THERE WERE THREE PATIENTS ON (B)(6) 2012 WITH DIFFUSE LAMELLAR KERATITIS (DLK) GRADE 3-4 AND TWO PATIENTS THE WEEK BEFORE. ALL FIVE WENT THROUGH A LIFT AND RINSE PROCEDURE, AND HAVE SINCE BEEN CLEARED WITH NO LOSS OF BEST CORRECTED VISUAL ACUITY (BCVA). DR (B)(6) WAS PARTICULARLY CONCERNED WITH ONE PATIENT THAT HE CLAIMED TO HAVE "INSTANT HAZE", WHERE A CLOUDY LIQUID WAS IMMEDIATELY PRESENT ON THE BACK OF THE FLAP. HE REFERRED TO IT AS A "LASER INDUCED REACTION". HE SCRAPED OFF THE HAZE, AND BROUGHT THE PATIENT BACK FOR A LIFT AND RINSE THE NEXT DAY. THE PATIENT IS NOW 20/25 UNCORRECTED VISUAL ACUITY (UCVA).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19080 INTRALASE FS2 FEMTOSECOND LASER HNO ABBOTT MEDICAL OPTICS 20005D

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R