BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 8081311 · Received November 16, 2018

    Report

    Report Number
    3006695864-2018-02138
    Event Type
    Injury
    Date Received
    November 16, 2018
    Date of Event
    July 16, 2018
    Report Date
    November 5, 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 (B)(4) 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 SURGERY ON (B)(6) 2018 AND PRESENTED ON (B)(6) 2018 BLURRY VISION AND GHOSTING IN RIGHT EYE. AS OF (B)(6) 2018 IT HAS NOT IMPROVED. PATIENT HAD HYPEROPIC TREATMENT. THE TOPICAL STEROID DOSAGE WAS INCREASED. IT WAS STATED THAT THE PATIENT HAD LOSS OF BEST CORRECTED VISUAL ACUITY (BCVA). THE PATIENT COMPLAINED OF GHOSTING AND CONSTANT BLURRY VISION IN RIGHT EYE. PATIENT WAS REFRACTED AND VISION IS SHARPER WHEN USING LENSES HOWEVER PATIENT REPORTED THAT THIS IS NOT AN OPTIMAL OPTION. PATIENT REPORTED SYMPTOMS ARE NOT INTERFERING WITH DAILY ACTIVITIES. PATIENT WILL BE ON LUMIFY EYEDROPS NOW (FOR SOME PUPILLARY CONSTRICTION) INSTEAD OF XIIDRA. PATIENT MAY NEED CUSTOM TREATMENT TO RESOLVE. BCVA FROM (B)(6) 2018: RIGHT EYE POST-OP 20/25 .00 X -.25 X 95, LEFT EYE POST-OP 20/20 .00 X .00 X 90.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    920286 INTRALASE FS2 FEMTOSECOND LASER HNO JOHNSON & JOHNSON SURGICAL VISION, INC 20003D

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention WAVELIGHT (B)(6)