BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 7343515 · Received March 15, 2018

    Report

    Report Number
    3006695864-2018-00529
    Event Type
    Injury
    Date Received
    March 15, 2018
    Date of Event
    February 14, 2018
    Report Date
    April 17, 2018
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC
    Product Code
    HNO
    UDI-DI
    05050474573451
    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). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE RECORDS RELATED TO THE DEVICE THAT INCLUDED LABELING, MANUALS, TRENDING, AND RISK DOCUMENTATION WAS PERFORMED. THE TREND REVIEW SHOWS THAT THERE IS NO SIGNIFICANT CHANGE OVER HISTORICAL COMPLAINT LIMITS AND NO RECOGNIZABLE ADVERSE TREND. THE RISKS AND MITIGATIONS ASSOCIATED WITH THE COMPLAINT ISSUE ARE IDENTIFIED IN EXISTING RISK DOCUMENTS AND NO NEW RISKS WERE IDENTIFIED AS PART OF THIS INVESTIGATION. THERE WAS NO PRODUCT DEFICIENCY IDENTIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    THE SURGERY CENTER REPORTED THAT A LASER VISION CORRECTION PATIENT EXPERIENCED FOREIGN BODY SENSATION ON THE LEFT EYE(OS) ON THE SAME DAY OF INITIAL TREATMENT. A BRIEF DESCRIPTION FROM THE SURGERY CENTER INDICATED THE PATIENT CAME IN FOR THE SAME DAY FOR A FOLLOW UP EXAM AS THE PATIENT EXPERIENCED A FOREIGN BODY SENSATION ON THE OS. THE PATIENT¿S CHIEF COMPLAINT WAS OF FOREIGN BODY SENSATION INFERIOR CORNEA ON OS WITH PHOTOSENSITIVITY. THE PATIENT¿S COMMENTS WERE OF DISCOMFORT. THE SURGERY CENTER NOTED THERE WAS AN IDIOPATHIC INFLAMMATORY REACTION ON THE OS. A FLAP RE-LIFT AND RINSE WAS PERFORMED SOON AFTER THE DISCOVERY. THE PATIENT WAS SEEN THE FOLLOWING DAY AND THERE WERE NO SIGNS OF INFLAMMATION, FLAP WAS CENTERED, AND NO EPI-INGROWTH. THE SURGERY CENTER REPORTED THE SYMPTOMS HAVE BEEN RESOLVED. BCVA FROM (B)(6) 2018: RIGHT EYE PRE-OP 20/20 -3.75 X -1.00 X 175, LEFT EYE PRE-OP 20/20 -4.00 X -1.00 X 5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186357 INTRALASE FS2 FEMTOSECOND LASER HNO JOHNSON & JOHNSON SURGICAL VISION, INC 20005D 05050474573451

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention