BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IFS

    MDR report key: 8926430 · Received August 23, 2019

    Report

    Report Number
    3006695864-2019-00678
    Event Type
    Injury
    Date Received
    August 23, 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
    SG
    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

    (B)(6). 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 OF THE DEVICE WAS NOT PROVIDED. CITATION: LOW, J., LIM, L., KOH, J., CHUA, D. AND ROSMAN, M. (2018). SIMULTANEOUS ACCELERATED CORNEAL CROSSLINKING AND LASER IN SITU KERATOMILEUSIS FOR THE TREATMENT OF HIGH MYOPIA IN ASIAN EYES. THE OPEN OPHTHALMOLOGY JOURNAL, 12(1), PP.241-241. A REVIEW OF RECORDS RELATED TO THE DEVICE INCLUDING LABELING, COMPLAINT TRENDING, AND RISK DOCUMENTATION WAS PERFORMED AND NO ISSUES WERE FOUND WITH THE EQUIPMENT. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    LITERATURE TITLE: SIMULTANEOUS ACCELERATED CORNEAL CROSSLINKING AND LASER IN SITU KERATOMILEUSIS FOR THE TREATMENT OF HIGH MYOPIA IN ASIAN EYES. LASIK XTRA IS A RECENTLY DESCRIBED TECHNIQUE WHICH COMBINES LASIK AND ACCELERATED CORNEAL CROSS-LINKING(CXL) IN THE SAME SETTING. ITS LONG-TERM OUTCOME IN ASIANS WITH HIGH MYOPIA IS NOT WELL DESCRIBED. TO COMPARE THE EFFICACY, PREDICTABILITY AND SAFETY OF LASIK XTRA WITH LASIK IN PATIENTS WITH HIGH MYOPIA. METHOD: THIS IS A RETROSPECTIVE STUDY COMPARING 50 CONSECUTIVE EYES UNDERGOING LASIK XTRA FOR THE CORRECTION OF HIGH MYOPIA AND/OR MYOPIC ASTIGMATISM (-6.63 TO -15.50 D MANIFEST SPHERICAL EQUIVALENT) WITH A MATCHED CONTROL GROUP OF 50 EYES UNDERGOING LASIK ALONE FOR CORRECTION OF HIGH MYOPIA (-6.00 TO -12.25 D MANIFEST SPHERICAL EQUIVALENT). MEAN FOLLOW-UP WAS 5.7 MONTHS (RANGE, 1.5-13.3 MONTHS) FOR LASIK XTRA AND 3.6 MONTHS (RANGE, 1.7-4.2 MONTHS) FOR LASIK ONLY. OUTCOME MEASURES INCLUDED UNCORRECTED DISTANCE VISUAL ACUITY (UDVA), CORRECTED DISTANCE VISUAL ACUITY (CDVA), REFRACTION AND INTRAOPERATIVE AND POSTOPERATIVE COMPLICATIONS. RESULTS: AT POST-OPERATIVE 3 MONTHS, ALL EYES ACHIEVED UDVA OF 20/40 OR BETTER, AND 80.0% OF LASIK XTRA EYES ACHIEVED UDVA OF 20/20 OR BETTER, COMPARED TO 66.0% OF LASIK ONLY EYES (P = 0.115). EFFICACY INDICES WERE 0.99±0.17 FOR LASIK XTRA AND 0.94±0.17 FOR LASIK ONLY (P = 0.164). THE PROPORTION OF EYES WITHIN ±0.50 D OF ATTEMPTED CORRECTION WAS 84% IN THE LASIK ONLY GROUP AND 72% IN THE LASIK XTRA GROUP AT POST-OPERATIVE 3 MONTHS (P = 0.148). SAFETY INDICES WERE 1.11±0.19 AND 1.11±0.18 IN THE LASIK XTRA AND LASIK ONLY GROUPS, RESPECTIVELY (P = 0.735). CONCLUSION: LASIK XTRA ACHIEVED COMPARABLE SAFETY, PREDICTABILITY AND EFFICACY AS LASIK IN PATIENTS WITH HIGH MYOPIA. GOOD REFRACTIVE STABILITY WAS ATTAINED AT 6-12 MONTHS. FURTHER LONG TERM STUDIES ARE REQUIRED TO DETERMINE WHETHER SIMULTANEOUS CXL IS ABLE TO REDUCE POSTOPERATIVE LASIK KERATECTASIA IN HIGH-RISK INDIVIDUALS. NOTE: ONE EYE WITH LOSS OF 2 LINES BCVA; 5 EYES WITH MILD POST OPERATIVE HAZE; 4 EYES WITH DIFFUSE LAMELLAR KERATITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    717892 IFS FEMTOSECOND LASER HNO JOHNSON & JOHNSON SURGICAL VISION, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other