BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 6084482 · Received November 7, 2016

    Report

    Report Number
    3006695864-2016-00924
    Event Type
    Injury
    Date Received
    November 7, 2016
    Date of Event
    October 12, 2016
    Report Date
    November 7, 2016
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HNO
    UDI-DI
    05050474573451
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, 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 PRESENTED WITH EPITHELIAL CELL INGROWTH ON BOTH EYES (OU) AT A 1 MONTH POST-OPERATIVE EXAM. A BRIEF DESCRIPTION FROM THE SURGERY CENTER INDICATED THERE WAS A SMALL SPOT OF EPITHELIAL INGROWTH NOTED ON BOTH EYES AT THE FLAP EDGE AT A 4 WEEK POST FLAP LIFT ENHANCEMENT. THROUGH FOLLOW UP, THE ENHANCEMENT (FLAP LIFTED) WAS PERFORMED DUE TO PATIENT'S VISUAL ACUITY WAS AT 20/60 ON BOTH EYES AND BLURRY VISION. AT THIS TIME, THERE IS NO PLAN OF ACTION FOR ADDITIONAL TREATMENT FOR THE EPITHELIAL INGROWTH. PRE-OP: BCVA FROM (B)(6) 2016: RIGHT EYE (OD) PRE-OP 20/20 2.75 X -.50 X 80; LEFT EYE (OS) PRE-OP 20/20 3.00 X -.75 X 97. POST-OP: BCVA FROM (B)(6) 2016: RIGHT EYE (OD) POST-OP 20/20 1.00 X -.50 X 65; LEFT EYE (OS) POST-OP 20/25 -.50 X -.50 X 135.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732456 INTRALASE FS2 FEMTOSECOND LASER HNO ABBOTT MEDICAL OPTICS 20005D 05050474573451

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention WAVELIGHT SERIAL NO. (B)(4)