BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 8892479 · Received August 14, 2019

    Report

    Report Number
    3006695864-2019-00657
    Event Type
    Injury
    Date Received
    August 14, 2019
    Date of Event
    July 22, 2019
    Report Date
    November 11, 2020
    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
    NY, 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 (B)(4) AND CAPA-010215.

    Additional Manufacturer Narrative · 1

    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 SURGERY ON (B)(6) 2019 AND PRESENTED ON (B)(6) 2019 WITH DIFFUSE LAMELLAR KERATITIS (DLK) IN BOTH EYES (OU). IT WAS NOTED THE RIGHT EYE (OD) HAD STAGE 1-2 DLK AND STAGE 3++ IN THE LEFT EYE (OS). IT WAS STATED THAT THE PATIENT EXPERIENCED LOSS OF BEST CORRECTED VISUAL ACUITY (BCVA). ORAL STEROID (MEDROL DOSE PACK TO BE TAPER) AND TOPICAL STEROID DOSAGE WAS INCREASED. IN ADDITION, A FLAP LIFT AND RINSE WERE PERFORMED. THE PATIENT REPORTED THE SYMPTOMS ARE NOT INTERFERING WITH DAILY ACTIVITIES. BCVA FROM (B)(6) 2019. RIGHT EYE PRE-OP 20/25 .00 X -1.25 X 88, LEFT EYE PRE-OP 20/25 -.50 X -2.25 X 91. BCVA FROM (B)(6) 2019. RIGHT EYE PRE-OP 20/25, LEFT EYE PRE-OP 20/60.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688724 INTRALASE FS2 FEMTOSECOND LASER HNO JOHNSON & JOHNSON SURGICAL VISION, INC. 20005D 05050474573451

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention WAVELIGHT SERIAL NO. (B)(6)| WAVELIGHT SERIAL NO. (B)(4).