BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 7157681 · Received January 2, 2018

    Report

    Report Number
    3006695864-2018-00003
    Event Type
    Injury
    Date Received
    January 2, 2018
    Date of Event
    December 1, 2017
    Report Date
    March 2, 2018
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    IN INITIAL REPORT, THE REPORTED ISSUE WAS INDICATED AS AFFECTING THE LEFT EYE (OS), HOWEVER, THE CORRECT EYE IS THE RIGHT EYE(OD). 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 ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    IN THE INITIAL REPORT, ¿REQUIRED INTERVENTION¿ WAS INADVERTENTLY SELECTED, HOWEVER, ¿OTHER SERIOUS¿ IS THE CORRECT OUTCOME ATTRIBUTED TO ADVERSE EVENT FOR THIS REPORT. 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 WAS EXPERIENCED LOSS OF BEST CORRECTED VISUAL ACUITY AND BLURRED VISION ON THE LEFT EYE (OS) AT A 5 MONTH POST OP EXAM. A BRIEF DESCRIPTION FROM THE SURGERY CENTER INDICATED THE PATIENT GOT WOOD PULP IN EYE 4 DAYS PRIOR TO COMING IN TO THE POST OP EXAM. THE PATIENT¿S CHIEF COMPLAINT WAS OF IRRITATION AND BLUR FROM A FOREIGN BODY. THE SURGERY CENTER REPORTED A LOSS OF BEST CORRECTED VISUAL ACUITY (BCVA) AND THAT THE EVENT IS LASTING AND DISABLING, SIGNIFICANTLY INTERFERING WITH DAILY ACTIVITIES. AT THIS TIME, THE PATIENT IS STILL BEING MANAGED. BCVA FROM (B)(6) 2017: RIGHT EYE PRE-OP 20/20 2.25 X -.25 X 85; LEFT EYE PRE-OP 20/20 2.25 X -.25 X 75. BCVA FROM (B)(6) 2017: RIGHT EYE POST-OP 20/20 -.25 X .00 X 90; LEFT EYE POST-OP 20/20 -2.25 X .00 X 90. BCVA FROM (B)(6) 2017: RIGHT EYE POST-OP 20/40 ; LEFT EYE POST-OP 20/20.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367 INTRALASE FS2 FEMTOSECOND LASER HNO ABBOTT MEDICAL OPTICS 20003D

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other| R WAVELIGHT SERIAL NO. (B)(4)