BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 9655706 · Received January 31, 2020

    Report

    Report Number
    3006695864-2020-00078
    Event Type
    Injury
    Date Received
    January 31, 2020
    Date of Event
    December 30, 2019
    Report Date
    November 3, 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

    CORRECTION: B3 - (B)(6) 2019.

    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 REVIEW OF RECORDS RELATED TO THE DEVICE INCLUDING LABELING, COMPLAINT TRENDING, AND RISK DOCUMENTATION WILL BE PERFORMED. UPON COMPLETION OF THIS REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. 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 INITIAL SURGERY IN 2018. PATIENT HAD ENHANCEMENT IN (B)(6) 2019 AND PRESENTED ON (B)(6) 2019 WITH EPITHELIAL INGROWTH IN LEFT EYE. THE TOPICAL STEROID DOSAGE WAS INCREASED. IT WAS STATED THAT THE PATIENT HAD NO LOSS OF BEST CORRECTED VISUAL ACUITY (BCVA). A FLAP LIFT AND RINSE WAS DONE. THE PATIENT COMPLAINED OF PERIPHERAL LIGHT SPECTRUM AND REPORTED THE VISION WAS UNACCEPTABLE FOR READING HOWEVER, WHEN ASKED IF SYMPTOMS ARE LASTING AND DISABLING AND/OR SIGNIFICANTLY INTERFERING WITH DAILY ACTIVITIES PATIENT ANSWERED THEY ARE NOT. BCVA FROM (B)(6) 2018: RIGHT EYE PRE-OP 20/20 -1.25 X -1.25 X 100, LEFT EYE PRE-OP 20/20 1.75 X -1.50 X 93. BCVA FROM (B)(6) 2019: RIGHT EYE POST-OP 20/20 .25 X .00 X 90, LEFT EYE POST-OP 20/20 -.25 X -.25 X 76.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118430 INTRALASE FS2 FEMTOSECOND LASER HNO JOHNSON & JOHNSON SURGICAL VISION, INC. 20003D

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention WAVELIGHT SERIAL NUMBER (B)(6).