BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IFS

    MDR report key: 9545647 · Received January 3, 2020

    Report

    Report Number
    3006695864-2020-00004
    Event Type
    Injury
    Date Received
    January 3, 2020
    Date of Event
    December 6, 2019
    Report Date
    November 4, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HNO
    UDI-DI
    05050474573468
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H4. DEVICE MANUFACTURE DATE (MM/DD/YYYY): 5/14/2009. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED. H3 OTHER TEXT : PLACEHOLDER.

    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

    MANUFACTURING DATE WAS NO AVAILABLE AT THE TIME OF THIS REPORT. (B)(4). THE SYSTEM WAS EVALUATED BY A FIELD SERVICE ENGINEER (FSE). FSE FOUND THE SIDECUT TO BE SLIGHTLY FOOTBALL SHAPED AND STRIKING GLASS IN ALL AREAS. FSE EVALUATED GALVO BLOCK AND FOUND Y GALVO FEEDBACK AT 1.80 WHEN COMMANDED TO 2.0V. FSE REPLACED THE GALVO BLOCK AND TESTED. VERIFIED ALIGNMENT THRU 6X TO OBJECTIVE LENS. PERFORMED Z BASELINE OFFSET CALIBRATION. GELLED LASER AT DR. SETTINGS AND VERIFIED SIDECUT RETRACE FUNCTION. MEASURED ENERGY AND DEPTH IN GEL. SYSTEM MEETS JOHNSON AND JOHNSON SPECS. 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 SURGEON HAD DIFFICULTY LIFTING FLAP OF THE RIGHT EYE (OD) AND WAS UNABLE TO LIFT THE FLAP OF THE LEFT EYE (OS). COMPLETED FLAP AND EXCIMER TREATMENT OD AND SWITCHED TO PHOTOREFRACTIVE KERATECTOMY (PRK) OS ON (B)(6) 2019. SURGEON MENTIONED THAT THE BEAM STEERING WAS VERY LOUD AND TOOK A LONG TIME LIKE 10 SECONDS PRIOR TO PERFORMING SIDE CUT ONLY ON OS. SURGEON ALSO MENTIONED THAT THERE WAS OPAQUE BUBBLE LAYER (OBL) PRESENT BY THE POCKET. UNCORRECTED VISUAL ACUITY (UCVA) AT 1 WEEK POST OP IS OD 20/16, OS 20/40. PATIENT WAS NOT REFRACTED AT 1 WEEK POST OP VISIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8490 IFS FEMTOSECOND LASER HNO JOHNSON & JOHNSON SURGICAL VISION, INC. J20007D 05050474573468

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Required Intervention