BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 5739419 · Received June 21, 2016

    Report

    Report Number
    3006695864-2016-00636
    Event Type
    Injury
    Date Received
    June 21, 2016
    Date of Event
    May 23, 2016
    Report Date
    June 21, 2016
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).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.

    Description of Event or Problem · 1

    THE CLINIC REPORTED THAT A LASER VISION CORRECTION PATIENT HAD SURGERY IN (B)(6) 2015. PATIENT SECONDARY PROCEDURE ON (B)(6) 2016 AND PRESENTED ON (B)(6) 2016 WITH DRY EYE AND PUNCTATE EPITHELIAL KERATITIS (PEK) IN BOTH EYES. A BRIEF DESCRIPTION OF THE EVENT SAYS THAT 1+ PEK WAS PRESENT IN RIGHT EYE AND 2+ PEK WAS NOTICED IN LEFT EYE WITH CENTRAL INVOLVEMENT. UNCORRECTED VISUAL ACUITY IN RIGHT EYE IS 20/20- AND IN LEFT EYE IS OS 20/50. INCREASED IN ARTIFICIAL TEARS IN BOTH EYES AND PRESCRIPTION FOR LOTEMAX TWICE A DAY FOR 2 WEEKS THEN AT BEDTIME FOR 2 WEEKS. STARTED PATIENT ON OMEGA 3'S 2000-3000MG/DAY. IT WAS STATED THAT THE PATIENT HAD NO LOSS OF BEST CORRECTED VISUAL ACUITY (BCVA). THE PATIENT COMPLAINED OF DRY EYE AND BLURRED VISION. PATIENT REPORTED SYMPTOMS ARE NOT INTERFERING WITH DAILY ACTIVITIES. BCVA (B)(6) 2015: RIGHT EYE PRE-OP 20/20 3.50 X -.50 X 81, LEFT EYE PRE-OP 20/20 2.25 X .00 X 90. BCVA FROM (B)(6) 2016: RIGHT EYE POST-OP INITIAL SURGERY 20/20 1 .00 X -.50 X 86, LEFT EYE POST-OP INITIAL SURGERY 20/20 .50 X -.50 X 96.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392016 INTRALASE FS2 FEMTOSECOND LASER HNO ABBOTT MEDICAL OPTICS 20005D

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention WAVELIGHT (B)(4)