BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAR S4 IR EX

    MDR report key: 8610110 · Received May 14, 2019

    Report

    Report Number
    3006695864-2019-00378
    Event Type
    Injury
    Date Received
    May 14, 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 Location
    KR
    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

    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). CITATION: JUN, I., JUNG, J., CHOI, Y., KIM, T., SEO, K. AND KIM, E. (2018). LONG-TERM CLINICAL OUTCOMES OF PHOTOTHERAPEUTIC KERATECTOMY IN CORNEAS WITH GRANULAR CORNEAL DYSTROPHY TYPE 2 EXACERBATED AFTER LASIK. JOURNAL OF REFRACTIVE SURGERY, 34(2), PP.132-139. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED. EQUIPMENT SAFETY INFORMATION INDICATES THE LASER IS CONTRAINDICATED FOR PATIENTS WITH CORNEAL ISSUES SUCH AS CORNEAL ABNORMALITIES, ABNORMAL CORNEAL TOPOGRAPHY, EPITHELIAL BASEMENT MEMBRANE DISEASE (EBMD) AND DEGENERATIONS OF THE STRUCTURE OF THE CORNEA.

    Description of Event or Problem · 1

    ARTICLE: LONG-TERM CLINICAL OUTCOMES OF PHOTOTHERAPEUTIC KERATECTOMY IN CORNEAS WITH GRANULAR CORNEAL DYSTROPHY TYPE 2 EXACERBATED AFTER LASIK. PURPOSE: TO INVESTIGATE THE LONG-TERM CLINICAL OUTCOMES AND RECURRENCE PATTERNS OF PHOTOTHERAPEUTIC KERATECTOMY (PTK) IN PATIENTS WITH GRANULAR CORNEAL DYSTROPHY TYPE 2 (GCD2) EXACERBATED AFTER LASIK. METHODS: FIFTY-ONE PATIENTS (76 EYES) WITH GCD2 EXACERBATED AFTER LASIK WHO UNDERWENT PTK BETWEEN JANUARY 2007 AND FEBRUARY 2017 WERE INCLUDED. PARTICIPANTS UNDERWENT OPHTHALMIC EXAMINATION, INCLUDING SLIT-LAMP MICROSCOPY, CORRECTED DISTANCE VISUAL ACUITY (CDVA), SLIT-LAMP PHOTOGRAPHY, AND FOURIER DOMAIN OPTICAL COHERENCE TOMOGRAPHY AT PREOPERATIVE AND POSTOPERATIVE VISITS. PTK WAS PERFORMED USING VISX S4 IR (VISX, INC., SANTA CLARA, CA). VISUAL ACUITY, COMPLICATIONS, INTERVAL, AND CONTRIBUTING FACTORS OF RECURRENCE WERE EVALUATED. RESULTS: THE FOLLOW-UP PERIOD RANGED FROM 1 TO 108 MONTHS (MEAN: 35.22 MONTHS). THE MEAN LOGMAR CDVA WAS 0.55 ± 0.43 (SNELLEN EQUIVALENT 20/80) PREOPERATIVELY AND 0.09 ± 0.43 (SNELLEN EQUIVALENT 20/25) AT 3 MONTHS POSTOPERATIVELY. FORTY-FIVE (61.6%) EYES DEVELOPED BIOMICROSCOPIC RECURRENCE AT A MEAN OF 18.6 MONTHS AFTER PTK; 20 (27.4%) EYES DEVELOPED SIGNIFICANT RECURRENCE AT A MEAN OF 31.3 MONTHS AFTER PTK. THE FLAP REMOVAL GROUP DEMONSTRATED BETTER CDVA AT 3 YEARS AFTER SURGERY AND LOWER RECURRENCE AND COMPLICATION RATES THAN THE FLAP CONSERVATION GROUP. MULTIVARIATE ANALYSIS REVEALED THAT FLAP REMOVAL REMARKABLY REDUCED THE RISK OF BOTH ANY SIGN OF AND SIGNIFICANT RECURRENCE. 6 EYES HAD COMPLICATIONS: 4 IN THE FLAP CONSERVATION GROUP WERE LISTED BECAUSE OF EPITHELIAL INGROWTH INTO THE FLAP INTERFACE. IN THE FLAP REMOVAL GROUP, CORNEAL OPACITY, WHICH IS NOT ASSOCIATED WITH GCD2, OCCURRED IN 1 EYE, AND LENS OPACITY OCCURRED IN 1 EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400403 STAR S4 IR EX EXCIMER LASER LZS JOHNSON & JOHNSON SURGICAL VISION, INC. 0030-6605

    Patients

    Seq Age Sex Outcome Treatment
    1 Other