BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 8627261 · Received May 21, 2019

    Report

    Report Number
    3006695864-2019-00399
    Event Type
    Injury
    Date Received
    May 21, 2019
    Date of Event
    May 10, 2019
    Report Date
    November 12, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    IN INITIAL REPORT, THE DATE OF EVENT PROVIDED WAS INADVERTENTLY REPORTED AS 5/13/2019, HOWEVER THE CORRECT DATE IS 5/10/2019. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC HAS BEEN SUBMITTED.

    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-(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) 2019 AND PRESENTED ON (B)(6) 2019 WITH EPITHELIAL INGROWTH IN THE RIGHT EYE (OD) AT POST OP EXAM. IT WAS STATED THAT THE PATIENT HAD NO LOSS OF BEST CORRECTED VISUAL ACUITY (BCVA). THE PATIENT COMPLAINED OF BLURRED VISION AND NOT IMPROVING IN THE RIGHT EYE. A SECONDARY PROCEDURE WAS REQUIRED TO REMOVE EPITHELIAL CELLS. PATIENT REPORTED SYMPTOMS ARE NOT INTERFERING WITH DAILY ACTIVITIES. PRE-OP BCVA FROM (B)(6) 2019:RIGHT EYE PRE-OP 20/20 -1.75 X -2.00 X 1.LEFT EYE PRE-OP 20/20 -2.25 X -.25 X 90.POST-OP FROM (B)(6) 2019:RIGHT EYE PRE-OP 20/20 1.75 X -1.75 X 102.LEFT EYE PRE-OP 20/20 .25 X -.50 X 9.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422373 INTRALASE FS2 FEMTOSECOND LASER HNO JOHNSON & JOHNSON SURGICAL VISION, INC. 20003D

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention WAVELIGHT S/N: (B)(4).| WAVELIGHT S/N: (B)(4)