BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 10425572 · Received August 19, 2020

    Report

    Report Number
    3006695864-2020-00395
    Event Type
    Injury
    Date Received
    August 19, 2020
    Date of Event
    July 28, 2020
    Report Date
    October 29, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS CORRECTION MDR IS BEING SUBMITTED TO ADDRESS INACCURATE INFORMATION IN SECTION F ON THE XML VERSION OF THE PREVIOUS SUBMISSION CAUSED BY A SOFTWARE GLITCH IN THE TRANSMISSION PROCESS. THE INTERNAL NON-CONFORMANCE NUMBERS FOR THIS SOFTWARE ISSUE ARE NR-0148919 AND CAPA-010215.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 MITIGATION 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. THE REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR FEMTOSECOND LASER SYSTEM SHOWED THAT THERE WERE NO ISSUES OR NON-CONFORMITIES. THE SYSTEM AND ITS COMPONENTS MET ALL SPECIFICATIONS PRIOR TO BEING RELEASED. MANUFACTURING HAS BEEN RULED OUT AS A POTENTIAL CAUSE FOR THE REPORTED ISSUE. BASED ON THE INVESTIGATION RESULTS, NO CORRECTIVE ACTION HAS BEEN ISSUED. BASED ON THE INVESTIGATION RESULTS THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. JOHNSON & JOHNSON SURGICAL VISION WILL CONTINUE TO MONITOR THIS TYPE OF COMPLAINTS. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LASER VISION CORRECTION PATIENT HAD SURGERY ON (B)(6) 2020 AND PRESENTED ON (B)(6) 2020 WITH FLAP STRIAE OF THE LEFT EYE. THE PATIENT COMPLAINED OF PAIN AND PERIPHERAL LIGHT SPECTRUM. A FLAP LIFT AND RINSE WAS PERFORMED. IT WAS STATED THAT THE PATIENT DID NOT EXPERIENCE LOSS OF BEST CORRECTED VISUAL ACUITY (BCVA), HOWEVER PATIENT SYMPTOMS WERE SIGNIFICANTLY INTERFERING WITH DAILY ACTIVITIES. BCVA FROM (B)(6) 2017: RIGHT EYE PRE-OP 20/15 -2.25 X -.50 X 80, LEFT EYE PRE-OP 20/20 -2.50 X -.25 X 150.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    892003 INTRALASE FS2 FEMTOSECOND LASER HNO JOHNSON & JOHNSON SURGICAL VISION, INC. 20003D

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Required Intervention WAVELIGHT 1010-3-278| WAVELIGHT (B)(4)