BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 8631364 · Received May 22, 2019

    Report

    Report Number
    3006695864-2019-00403
    Event Type
    Injury
    Date Received
    May 22, 2019
    Date of Event
    April 26, 2019
    Report Date
    November 12, 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
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    IN INITIAL REPORT, THE MANUFACTURER DATE PROVIDED WAS INADVERTENTLY REPORTED AS 03/31/2009, HOWEVER THE CORRECT DATE IS 04/08/2009. 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-0148919 AND CAPA-010215.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SYSTEM WAS EVALUATED BY A FIELD SERVICE ENGINEER. THE FIELD SERVICE CHECKED SIDECUT RETRACE, TILT AND OVERLAP AND ADJUSTED THE TILT DOWN TO 3. THE SYSTEM MEETS JOHNSON & JOHNSON SPECIFICATIONS. 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 WHICH RESULTED IN SIDECUT TAGS IN THE LEFT EYE (OS). THE DOCTOR WAS ABLE TO COMPLETE THE SIDE CUT AND A PARTIAL LIFT WAS PERFORMED WITH ROOM TO ADEQUATELY TREAT IN ABLATION ZONE. THE PATIENT WAS TREATED SUCCESSFULLY. IT WAS NOTED THAT THERE WAS LOSS OF BEST CORRECTED VISUAL ACUITY (BCVA). BCVA PRE-OP: 20/15; BCVA PO: 20/25.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427545 INTRALASE FS2 FEMTOSECOND LASER HNO JOHNSON & JOHNSON SURGICAL VISION, INC. 20005D 05050474573451

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention