BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 4863431 · Received June 23, 2015

    Report

    Report Number
    3006695864-2015-00313
    Event Type
    Injury
    Date Received
    June 23, 2015
    Date of Event
    May 30, 2015
    Report Date
    August 25, 2015
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: THE FOLLOWING INFORMATION WAS INADVERTENTLY NOT INCLUDED IN THE INITIAL REPORT. BEST CORRECTED VISUAL ACUITY (BCVA) FROM (B)(6) 2015 RIGHT EYE PRE-OP 20/20 -3.75 X -.25 X 105; LEFT EYE PRE-OP 20/20 -3.00 X -.25 X 145. IN ADDITION IT WAS INDICATED IN THE INITIAL MDR THAT ''PATIENT'S CHIEF COMPLAINT WAS DOING WELL'' WHEN IT SHOULD HAVE SAID PATIENT HAS NO COMPLAINTS AND COMMENTED DOING GREAT. ADDITIONAL INFORMATION: EQUIPMENT LABELING PROVIDES POTENTIAL ADVERSE EFFECTS THAT CAN BE CAUSED BY THE SURGICAL/TREATMENT PROCEDURE BEING PERFORMED. THE OPERATOR MANUALS FOR THE VARIOUS EQUIPMENT WERE REVIEWED AND DETERMINED TO INCLUDE ADEQUATE WARNINGS FOR MEDICAL COMPLICATIONS. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE CLINIC IS REPORTING THIS ADVERSE EVENT ONLY AND DID NOT REQUEST OR REQUIRE FIELD SERVICE OR CLINICAL SUPPORT. 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 DIFFUSE LAMELLAR KERATITIS (DLK) STAGE 1 ON BOTH EYES (OU) AT 1 DAY POST-OPERATIVE EXAM. THE BRIEF DESCRIPTION OF THE EVENT WAS THAT THERE WAS TRACE OF DLK UNDER THE SUPERIOR SECTION OF THE FLAP IN BOTH EYES. TOPICAL STEROID DOSAGE WAS INCREASED TO TREAT THE DLK. THE PATIENT RESPONDED TO TREATMENT AND THE DLK HAS BEEN RESOLVED. THE PATIENT¿S CHIEF COMPLAINT WAS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404655 INTRALASE FS2 FEMTOSECOND LASER HNO ABBOTT MEDICAL OPTICS 20003D

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention