BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 5555457 · Received April 7, 2016

    Report

    Report Number
    3006695864-2016-00368
    Event Type
    Injury
    Date Received
    April 7, 2016
    Date of Event
    March 11, 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 SURGERY CENTER REPORTED THAT A LASER VISION CORRECTION PATIENT WAS PRESENTED WITH AN INFECTION/INFLAMMATION ON THE RIGHT EYE (OD) AT A 3 MONTH POST-OPERATIVE EXAM. A BRIEF DESCRIPTION FROM THE SURGERY CENTER INDICATED THAT THE PATIENT NOTES SOME BLUR VISION ON THE RIGHT EYE. THE SLIT LIGHT EXAM SHOWED 3 + PUNCTATE EPITHELIAL KERATOPATHY (PEK) EXTENDING PAST THE FLAP MARGINS AS WELL AS POSSIBLE SUBEPITHELIAL INFILTRATES (SEI). THE PATIENT COMMENTS WERE OF DRY AND SOME BLURRY VISION ON RIGHT EYE MORE THAN THE LEFT EYE. TOPICAL STEROIDS (PRED FORTE EVERY 2 HOURS WITH TAPER) WERE USED TO TREAT THE SYMPTOMS. BCVA FROM (B)(6) 2015: RIGHT EYE PRE-OP 20/20 -2.25 X -.50 X 92, LEFT EYE PRE-OP 20/20 -2.00 X -.75 X 4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214866 INTRALASE FS2 FEMTOSECOND LASER HNO ABBOTT MEDICAL OPTICS 20005D

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Required Intervention WAVELIGHT SERIAL NO. (B)(4)