BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE

    MDR report key: 3274503 · Received August 9, 2013

    Report

    Report Number
    3006695864-2013-00319
    Event Type
    Injury
    Date Received
    August 9, 2013
    Date of Event
    July 8, 2013
    Report Date
    July 8, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION - AMO (B)(4) MADE A PHONE CALL TO (B)(6) AND COMMUNICATED WITH A LASER TECHNICIAN. THE LASER TECHNICIAN CONFIRMED THAT ALL THE PATIENTS HAVE BEEN CLINICALLY RECOVERED AND THERE IS NO ISSUE. WHAT THE TECHNICIAN MENTIONED IS STATED IN THE ARTICLE. NO ADVERSE EVENT IS PRESENT. ALL THE PATIENT INTERFACES WERE PERSONALLY IMPORTED BY THE (B)(6). NO PRODUCT IS RETURNED FOR INVESTIGATION. NOTE: ALL PERTINENT INFORMATION AVAILABLE TO AMO AT THE TIME OF THIS REPORT HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    STUDY WAS CONDUCTED IN JULY 2010. PLACEHOLDER.

    Description of Event or Problem · 1

    IN CLINICAL OPHTHALMOLOGY 2013:7 1365-1371, AN ARTICLE WAS PUBLISHED: "COMPARISON OF DLK INCIDENCE AFTER LASER IN SITU KERATOMILEUSIS ASSOCIATED WITH TWO FEMTOSECOND LASERS; FEMTO LDV AND INTRALASE FS60" (2013, TOMITA ET AL.). IN THE RESULTS OF THE ARTICLE, IT STATES THAT THERE WAS A STATISTICAL DIFFERENCE (P<0.0001) IN THE DIFFUSE LAMELLAR KERATITIS (DLK) INCIDENCE RATE BETWEEN PATIENTS THAT HAD SURGERY WITH A ABBOTT MEDICAL OPTICS INTRALASE FS60 FEMTOSECOND LASER AND THE ZIEMER OPHTHALMIC SYSTEMS FEMTO LDV. THE INTRALASE FEMTOSECOND GROUP HAD 304 EYES OF 152 PATIENTS (100 MEN AND 52 WOMEN) FROM WHICH 114 (37.5%) HAD DLK. THE MEAN AGE FOR THE GROUP WAS OF 30.61 YEARS ± 7.05 (RANGE: 18 TO 54 YEARS) HAD BILATERAL LASIK WITH INTRALASE FS60. PATIENTS HAD EXCELLENT VISUAL AND REFRACTIVE OUTCOMES. ALTHOUGH LOW LEVELS OF DLK WERE OBSERVED, THEY DID NOT AFFECT VISUAL ACUITY. THE FEMTOSECOND LASER DID NOT INDUCED HIGH LEVELS OF DLK, AND ANY POSTOPERATIVE DLK CLEARED UP WITHIN 1 WEEK. THEREFORE, LASERS PROVIDE EXCELLENT RESULTS, WITH NO CLINICAL DIFFERENCES, AND EXCEL AT FLAP CREATION FOR LASIK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380010 INTRALASE FEMTOSECOND LASER HNO ABBOTT MEDICAL OPTICS 20005J

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other INTRALASE MODEL20005J, (B)(4)