BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE

    MDR report key: 8677031 · Received June 6, 2019

    Report

    Report Number
    3006695864-2019-00462
    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
    ES
    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 NR-0148919 AND CAPA-010215.

    Additional Manufacturer Narrative · 1

    EXPIRATION DATE: UNKNOWN. CATALOG: UNKNOWN. SERIAL NUMBER: UNKNOWN. DEVICE IS NOT RETURNED FOR EVALUATION AS IT NOT KNOW ; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD, LABELING, COMPLAINT TRENDING, AND RISK DOCUMENTATION FOR THIS DEVICE WILL NOT BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. DEVICE MANUFACTURE DATE ; NOT AVAILABLE DUE THE FACT THAT NO IDENTIFICATION AVAILABLE. (B)(4). CITATION: PERIS-MARTÍNEZ, C., BUENO-GIMENO, I., ALVAREZ-ARANA, I., PIÑERO, D. AND GENÉ-SAMPEDRO, A. (2018). CHARACTERIZATION OF THE EFFECT OF INTRACORNEAL RING SEGMENT IN CORNEAL ECTASIA AFTER LASER REFRACTIVE SURGERY. EUROPEAN JOURNAL OF OPHTHALMOLOGY, P.112067211880896. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    TITLE: CHARACTERIZATION OF THE EFFECT OF INTRACORNEAL RING SEGMENT IN CORNEAL ECTASIA AFTER LASER REFRACTIVE SURGERY. PURPOSE: TO EVALUATE THE VISUAL, REFRACTIVE, TOPOGRAPHIC, PACHYMETRIC, AND BIOMECHANICAL OUTCOMES AFTER INTRACORNEAL RING SEGMENT IMPLANTATION IN CORNEAS WITH POST-LASIK ECTASIA. METHODS: RETROSPECTIVE LONGITUDINAL STUDY ENROLLING 26 EYES OF 22 PATIENTS WITH POST-LASIK ECTASIA AND UNDERGOING INTRACORNEAL RING SEGMENT IMPLANTATION (KERARING®, MEDIPHACOS) USING A 60-KHZ FEMTOSECOND LASER (INTRALASE®,INTRALASE CORP.) FOR CORNEAL TUNNELIZATION. VISUAL, REFRACTIVE, ANTERIOR, AND POSTERIOR CORNEAL TOPOGRAPHIC (PENTACAM HR, OCULUS), PACHYMETRIC, AND CORNEAL BIOMECHANICAL CHANGES (OCULAR RESPONSE ANALYZER, REICHERT) WERE EVALUATED DURING A 12-MONTH FOLLOW-UP. VECTOR ANALYSIS OF ASTIGMATIC CHANGES WAS PERFORMED. NOTE: ONE PATIENT ECTASIA CONTINUE TO PROGRESS SIGNIFICANTLY AFTER IMPLANTATION OF THE RING SEGMENTS AND REQUIRED LAMELLAR KERATOPLASTY AT 7 MONTHS (POST RING IMPLANTATION).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466744 INTRALASE FEMTOSECOND LASER HNO JOHNSON & JOHNSON SURGICAL VISION, INC. 20005J

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention