BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 5420574 · Received February 9, 2016

    Report

    Report Number
    3006695864-2016-00116
    Event Type
    Injury
    Date Received
    February 9, 2016
    Report Date
    February 9, 2016
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UDI #: (B)(4). EVENT DATE: NO SURGERY DATES WERE GIVEN. APPLICATIONS SUPPORT MANAGER WAS AT THE ACCOUNT WHEN THE SURGEON REPORTED THE EVENTS AND SHE WAS TOLD THAT SURGEON RECENTLY CHANGED THE ENERGY BED FROM 1.10 TO 0.95. INTRALASE LAST SERVICED IN DECEMBER 2015. NO CHANGE IN OPERATING ROOM SUPPLIES OR MEDICATIONS. USES DISPOSABLE CANNULA AND SYRINGE. CLEANS THE FOLLOWING INSTRUMENTS WITH DISTILLED WATER PRIOR TO STATIM 5000 STEAM STERILIZER: CORNEAL MARKER, SPECULUM, AND FLAP LIFTER. RINSES UNDER FLAP WITH BSS. NEW STATIM 5000 WITH OLDER TUBING AND RESERVOIR. ACCOUNT COULD NOT RECALL WHEN TUBING AND RESERVOIR WERE LAST CHANGED. MOVED TO NEW FACILITY LAST SUMMER. OBSERVED NO CONSTRUCTION OR REMODELING DURING VISIT. THERE IS A NEW SCRUB TECH. ACCOUNT COMMENTED STATIM 5000 IS DRAINED MONTHLY AND PERFORMS SPORE TESTING WEEKLY. OBSERVED NO STEAM INDICATOR STRIPS USED FOR EACH CYCLE DURING VISIT. STATIM 5000 LOCATED IN LASER SUITE. DISTILLED WATER IS USED IN STATIM 5000 AND CLEANING BOWLS. USES NONSTERILE (B)(4) POWDER-FREE VINYL EXAM GLOVES OR NON-STERILE ROYAL SHIELD POWDER-FREE MEDICAL EXAMINATION GLOVES. OBSERVED NO INTRAOPERATIVE PACHYMETRY, NO COMPRESSED AIR USED TO DRY CORNEA, AND NO PUNCTAL PLUGS. OBSERVED CLEAN LASER SUITE. OBSERVED SURGICAL SUPPLIES ARE PRE-SET UP AND LEFT OUT IN (B)(4) BAG OR ON A CART SUCH AS MEDLINE MAYO STAND COVERS, EYELID DRAPES, WECK CELLS, BSS, AND CORNEAL SKIN MARKERS. OBSERVED (B)(4) HAND SANITIZER OR GERM-X HAND SANITIZER IS USED PRIOR TO PUTTING ON GLOVES. ACCOUNT COMMENTED THEY USE SAME BOTTLES OF EYE DROP MEDICATIONS AFTER SURGERY ON MULTIPLE SURGERY DAYS: OFLOXACIN OPHTHALMIC SOLUTION 0.3 PERCENT EYEDROPS, PREDNISOLONE ACETATE 1 PERCENT EYEDROPS, AND DICLOFENAC SODIUM OPHTHALMIC SOLUTION 0.1 PERCENT EYEDROPS. NEW BOTTLE OF PROPARACAINE EYEDROPS EACH SURGERY DAY. OBSERVED CLEANING BOWL WAS NOT CHANGED BETWEEN CASES. DISCUSSED WITH THE ACCOUNT TO FOLLOW STATIM 5000'S MANUFACTURER'S CLEANING AND STERILIZING RECOMMENDATIONS. DISCUSSED WITH SURGEON AND STAFF MANY FACTORS CAN INFLUENCE DLK AND TO REVIEW CLEANING REGIME AND STERILITY IN LASER SUITE. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    SURGEON REPORTED TRACE TO GRADE 1 DLK ON 20% OF ILASIK CASES AT THE 1 DAY POST TREATMENT IN BOTH EYES; NO PATIENT DETAILS WERE PROVIDED. SURGEON INCREASED PREDNISOLONE ACETATE 1% EYEDROP REGIMEN POST OPERATION AND RESOLVED IN 1 WEEK ON ALL CASES. NO LOSS IN VISION REPORTED AND NO OTHER MEDICAL OR SURGICAL INTERVENTION REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83025 INTRALASE FS2 FEMTOSECOND LASER HNO ABBOTT MEDICAL OPTICS 20003

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention