BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAR S4 IR EX

    MDR report key: 8602136 · Received May 10, 2019

    Report

    Report Number
    3006695864-2019-00365
    Event Type
    Injury
    Date Received
    May 10, 2019
    Report Date
    November 12, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    LZS
    PMA / PMN Number
    P930016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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 COPY OF THE ARTICLE IS PROVIDED WITH THIS REPORT. CITATION: KAMIYA, K., TAKAHASHI, M., IGARASHI, A. AND SHOJI, N. (2019). CENTRAL ISLANDS AND VISUAL OUTCOMES OF PHOTOTHERAPEUTIC KERATECTOMY USING THE PHOTOREFRACTIVE KERATECTOMY MODE. CORNEA, 38(1), PP.89-92. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    ARTICLE: CENTRAL ISLANDS AND VISUAL OUTCOMES OF PHOTOTHERAPEUTIC KERATECTOMY USING THE PHOTOREFRACTIVE KERATECTOMY MODE. PURPOSE: TO COMPARE THE RATE OF CENTRAL ISLAND (CI) AND VISUAL ACUITY AFTER PHOTOTHERAPEUTIC KERATECTOMY (PTK) WITH AND WITHOUT THE CI PROGRAM. METHODS: THIS RETROSPECTIVE STUDY COMPRISED 147 EYES OF 89 CONSECUTIVE PATIENTS (MEAN AGE 6 SD, 71.1 6 9.6 YEARS) UNDERGOING PTK WITH AND WITHOUT THE ANTI-CI PROGRAM [PHOTOREFRACTIVE KERATECTOMY (PRK) MODE AND PTK MODE] USING THE VISX STAR S4 EXCIMER LASER SYSTEM (JOHNSON & JOHNSON VISION, (B)(6), US) FOR TREATMENT OF BAND KERATOPATHY (BK) OR GRANULAR CORNEAL DYSTROPHY (GCD). THE RATE OF CI FORMATION, DEFINED AS A STEEPENING AREA OF 3 D, 1.5 MM IN DIAMETER, ON EACH CORNEAL VIDEOKERATOGRAPHER (ATLAS 9000; CARL ZEISS MEDITEC, JENA), AND BEST SPECTACLE-CORRECTED VISUAL ACUITY (BSCVA) WERE ASSESSED 3 MONTHS AFTER PTK. RESULTS: CENTRAL ISLAND FORMATION IN 17 EYES (22%) IN THE PHOTOREFRACTIVE KERATECTOMY MODE GROUP AND 45 EYES IN THE PTK MODE GROUP AT 3 MONTHS POSTOPERATIVELY (P , 0.001, X2 TEST). POSTOPERATIVE LOGARITHM OF THE MINIMAL ANGLE OF RESOLUTION BSCVA WAS 0.10 6 0.14 IN THE PRK GROUP AND 0.15 6 0.13 IN THE PTK GROUP (P = 0.019, STUDENT T TEST). THE RATE OF CI WAS 13 EYES (33%) WITH BK AND 6 EYES (15%) WITH GCD IN THE PRK MODE GROUP AND 25 EYES (83%) WITH BK AND 20 EYES (71%) WITH GCD IN THE PTK MODE GROUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394544 STAR S4 IR EX EXCIMER LASER LZS JOHNSON & JOHNSON SURGICAL VISION, INC. 0030-6605

    Patients

    Seq Age Sex Outcome Treatment
    1 Other