BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS3

    MDR report key: 8338636 · Received February 14, 2019

    Report

    Report Number
    3006695864-2019-00125
    Event Type
    Injury
    Date Received
    February 14, 2019
    Date of Event
    January 18, 2019
    Report Date
    November 9, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 · 0

    IN INITIAL REPORT, THE MANUFACTURER DATE PROVIDED WAS INADVERTENTLY REPORTED AS 11/30/2005, HOWEVER THE CORRECT DATE IS 12/5/2005. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC HAS BEEN SUBMITTED.

    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

    AN APPLICATION SUPPORT MANAGER (ASM) WAS AT SITE FOR DIDACTIC WET LAB ON (B)(6) 2019 AND DURING THE VISIT THE DOCTOR REPORTED THAT EARLIER IN THE DAY HE PERFORMED INTRALASE ON A PATIENT AND NOTICED A VERTICAL GAS BREAKTHROUGH (VGB) IN THE LEFT EYE (OS) WHICH OCCURRED DURING THE PROCEDURE. THE RIGHT EYE WAS PERFORMED WITHOUT ANY COMPLICATIONS. THE DOCTOR OPTED NOT TO THE LIFT THE FLAP OF NEITHER EYE. DOCTOR REPORTED THAT THERE MIGHT HAVE BEEN A CORNEAL SCAR. THE PATIENT WILL BE BROUGHT BACK AT A LATER DATE TO PERFORM PHOTOREFRACTIVE KERATECTOMY (PRK) IN BOTH EYES (OU).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133923 INTRALASE FS3 FEMTOSECOND LASER HNO JOHNSON & JOHNSON SURGICAL VISION, INC. 20004

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention