BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IFS

    MDR report key: 8676772 · Received June 6, 2019

    Report

    Report Number
    3006695864-2019-00460
    Event Type
    Injury
    Date Received
    June 6, 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
    SA
    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

    SERIAL#: UNKNOWN/NOT PROVIDED UDI #: A COMPLETE UDI # IS UNKNOWN AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. DEVICE MANUFACTURE DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. (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. A COPY OF THE ARTICLE IS PROVIDED WITH THIS REPORT. CITATION: ANNAKHLI, F. AND KHATTAK, A. (2017). VECTOR ANALYSIS OF FEMTOSECOND LASER-ASSISTED ASTIGMATIC KERATOTOMY AFTER DEEP ANTERIOR LAMELLAR KERATOPLASTY AND PENETRATING KERATOPLASTY. INTERNATIONAL OPHTHALMOLOGY, 39(1), PP.189-198. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    TITLE: VECTOR ANALYSIS OF FEMTOSECOND LASER-ASSISTED ASTIGMATIC KERATOTOMY AFTER DEEP ANTERIOR LAMELLAR KERATOPLASTY AND PENETRATING KERATOPLASTY. PURPOSE: TO COMPARE THE REFRACTIVE AND KERATOMETRIC CHANGES INDUCED BY FEMTOSECOND LASER ASTIGMATIC KERATOTOMY (AK) FOR SUTURE-OUT POST-KERATOPLASTY ASTIGMATISM IN DEEP ANTERIOR LAMELLAR KERATOPLASTY (GROUP I) AND PENETRATING KERATOPLASTY (GROUP II). METHODS: THIS STUDY COMPRISED 15 EYES IN GROUP I AND 35 EYES IN GROUP II. ALL EYES UNDERWENT FEMTOSECOND AK FOR SUTURE-OUT POST-KERATOPLASTY ASTIGMATISM. THE REFRACTIVE AND KERATOMETRIC MEASUREMENTS WERE EVALUATED BEFORE AND 6 MONTHS AFTER AK. THE ALPINS METHOD FOR VECTOR ANALYSIS WAS USED TO EVALUATE THE KERATOMETRIC CHANGES INDUCED BY AK. NOTE: IT WAS REPORTED THAT 1 EYE FROM THE STUDY HAD ISSUES: ONE EYE WITH FAILED GRAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467914 IFS FEMTOSECOND LASER HNO JOHNSON & JOHNSON SURGICAL VISION, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other