BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 7239153 · Received February 2, 2018

    Report

    Report Number
    3006695864-2018-00197
    Event Type
    Injury
    Date Received
    February 2, 2018
    Date of Event
    January 6, 2018
    Report Date
    March 7, 2018
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HNO
    UDI-DI
    05050474573451
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    A RECORD REVIEW WAS PERFORMED. A PRODUCT DEFICIENCY REVIEW WAS PERFORMED AND THERE IS NO PRODUCT DEFICIENCY IDENTIFIED. A DOCUMENT, SERVICE HISTORY, AND TRENDING WAS REVIEWED. THERE IS NOT A 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. A LABELING REVIEW WAS CONDUCTED; THE OPERATOR MANUAL FOR THE SYSTEM WAS REVIEWED AND FOUND TO INCLUDE ADEQUATE INSTRUCTIONS FOR USE, WARNINGS AND OPERATIONAL ERRORS. 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 PRESENTED WITH DIFFUSE LAMELLAR KERATITIS (DLK) STAGE 3+ ON BOTH EYES (OU) AT 1-DAY POST-OPERATIVE EXAM. ORAL STEROIDS (PRED FORTE) WERE PRESCRIBED AND TOPICAL STEROID DOSAGE WAS INCREASED TO RESOLVE SYMPTOMS. BEST CORRECTED VISUAL ACUITY (BCVA) FROM (B)(6) 2017: RIGHT EYE PRE-OP 20/20 -4.00 X -1.50 X 170, LEFT EYE PRE-OP 20/20 -3.75 X -1.25 X 10. UNCORRECTED VISUAL ACUITY (UCVA) FROM (B)(6) 2018: RIGHT EYE POST-OP 20/20, LEFT EYE POST-OP 20/20. THIS REPORT IS FOR THE FEMTO LASER. A SEPARATE REPORT WILL BE SUBMITTED FOR THE EXCIMER LASER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79189 INTRALASE FS2 FEMTOSECOND LASER HNO ABBOTT MEDICAL OPTICS 20005D 05050474573451

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Required Intervention