BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 4813335 · Received June 2, 2015

    Report

    Report Number
    3006695864-2015-00246
    Event Type
    Injury
    Date Received
    June 2, 2015
    Date of Event
    April 22, 2015
    Report Date
    September 15, 2015
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CLINIC IS REPORTING THIS ADVERSE EVENT ONLY. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DURING FOLLOW UP WITH THE ACCOUNT THEY REPORTED THAT THERE WAS NO RECENT SERVICE TO THE LASER PRIOR TO THE DLK EVENTS. THEY REPORTED THAT THERE HAS BEEN NO FLAP SETTING CHANGES RECENTLY OR STAFF HAVE INTRODUCED ANYTHING NEW RECENTLY. THERE HAS BEEN NO OTHER SURGEONS OBSERVING DLK CASES AND WHEN ASKED THE LOCATION CONTACT SAID THAT THERE HAS BEEN NOTHING CONCRETE AS TO WHAT HAD CAUSED THE DLK. HOWEVER, SHE HAS MADE THE OBSERVATION THAT THE SURGEON IS NOT THOROUGH WHEN WASHING HANDS AND HE DOES NOT WEAR STERILE GLOVES IN THE LASIK SUITE.

    Additional Manufacturer Narrative · 1

    UDI: (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    CORRECTION: IN INITIAL REPORT, THE DESCRIPTION OF THE STATED ¿TOPICAL STEROID DOSAGE WAS USED TO TREAT DLK", HOWEVER, IT SHOULD REFLECT TOPICAL STEROID WAS INCREASED. CORRECTION: IN INITIAL REPORT, IT WAS STATED THAT THE CLINIC IS REPORTING THIS ADVERSE EVENT ONLY. HOWEVER, THE CLINIC REQUESTED CLINICAL SUPPORT. AN APPLICATION SUPPORT MANAGER VISITED THE ACCOUNT AND A TECHNICIAN FROM THE SURGERY CENTER MADE THE OBSERVATION THAT THE SURGEON WAS NOT THOROUGH WHEN HAND WASHING BETWEEN THE EYES. THE AMO REPRESENTATIVE DISCUSSED THE FACT THAT THE PERSON SCRIBING THE CASE WORE DISPOSABLE NON STERILE GLOVES AND PROVIDED INSTRUCTIONS TO CHANGE BY USING THE CORRECT GLOVES. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    Description of Event or Problem · 1

    THE SURGERY CENTER REPORTED THAT A LASER VISION CORRECTION PATIENT WAS PRESENTED WITH STAGE 1-2 + OF DIFFUSE LAMELLAR KERATITIS (DLK). TOPICAL STEROID (PRED FORTE) DOSAGE WAS USED TO TREAT DLK. THE SURGERY CENTER REPORTED THE LAST SURGERY DAY; FOUR OUT OF SEVEN PATIENTS WERE DIAGNOSED WITH DLK. THE SURGERY CENTER INDICATED THEY HAVE NOT CHANGED SURGICAL SETTINGS AND ALL CASES HAD BED ENERGY OF 1.00, SPOT 7, AND LINE 7. THIS IS FOR SECOND PATIENT. THE DLK HAS BEEN RESOLVED. PRE-OP BCVA 20/20 POST-OP BCVA 20/20.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354437 INTRALASE FS2 FEMTOSECOND LASER HNO ABBOTT MEDICAL OPTICS 20003

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention