BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 4182507 · Received October 17, 2014

    Report

    Report Number
    3006695864-2014-00458
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    September 22, 2014
    Report Date
    September 3, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    PLACEHOLDER.

    Description of Event or Problem · 1

    THE CLINIC REPORTED THAT A LASER VISION CORRECTION PATIENT DEVELOPED EPITHELIAL INGROWTH IN THE LEFT EYE (OS) AT ONE MONTH POST OP EXAM. IN ADDITION, THE SURGERY CENTER NOTED THE RIGHT EYE (OD) AT ONE MONTH POST OP EXAM HAD A TRACE OF EPITHELIAL NESTLED AT THE FLAP EDGE. THE PATIENT¿S CHIEF COMPLAINT WAS DISTANT VISUAL ACUITY (DVA) WAS BLURRY AND THE NEAR VISION ACUITY (NVA) WAS BETTER THAN EXPECTED. AT THE TIME OF ONE MONTH VISION, THERE WAS NO SURGICAL OR MEDICAL INTERVENTION REQUIRED AND THERE WAS NO REPORT OF LOSS OF BEST CORRECT VISUAL ACUITY (BCVA). AT THREE MONTH POST OP EXAM, THE CLINIC REPORTED THE PATIENT DEVELOPED CORNEAL ABRASIONS ON LEFT EYE(OS) RESULTING IN LOSS OF 2 LINES OF BCVA. THE PATIENT CHIEF COMPLAINTS WERE DRY EYE, EXTREMELY BLURRY VISION ON LEFT EYE (OS), MILD DISCOMFORT REQUIRING ARTIFICIAL TEAR EYE DROPS. VISION ACUITY(VA) RECOVERED IN A COUPLE OF DAYS. THROUGH FOLLOW UP, THE CLINIC CLARIFIED THE PATIENT DID NOT HAVE EPITHELIAL INGROWTH AND THAT PATIENT HAD CORNEAL EROSION/DRYNESS RESULTING IN DECREASED BCVA OF 2 LINES BEFORE SURGERY. THE PATIENT HAS BEEN GIVEN INSTRUCTIONS TO USE ARTIFICIAL TEARS FREQUENTLY AND TO USE ARTIFICIAL TEAR GEL AT NIGHT. CLINIC EXPECTS THE PATIENT WILL IMPROVE ONCE THE EROSION/DRYNESS RESOLVES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661141 INTRALASE FS2 FEMTOSECOND LASER HNO ABBOTT MEDICAL OPTICS 20005D

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other WAVELIGHT SERIAL NO. (B)(4)