BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE

    MDR report key: 8926659 · Received August 23, 2019

    Report

    Report Number
    3006695864-2019-00679
    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
    HK
    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

    DATE OF EVENT - NOT PROVIDED. SERIAL #: UNKNOWN/NOT PROVIDED. UDI #: A COMPLETE UDI # IS UNKNOWN AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. (B)(6). DEVICE MANUFACTURE DATE: UNKNOWN, AS THE LOT NUMBER OF THE DEVICE WAS NOT PROVIDED. 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. CITATION: CHAN, T., WANG, Y., NG, A., ZHANG, J., YU, M., JHANJI, V. AND CHENG, G. (2018). VECTOR ANALYSIS OF HIGH (=3 DIOPTERS) ASTIGMATISM CORRECTION USING SMALL-INCISION LENTICULE EXTRACTION AND LASER IN SITU KERATOMILEUSIS. JOURNAL OF CATARACT & REFRACTIVE SURGERY, 44(7), PP.802-810. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    LITERATURE TITLE: VECTOR ANALYSIS OF HIGH (>=3 DIOPTERS) ASTIGMATISM CORRECTION USING SMALL-INCISION LENTICULE EXTRACTION AND LASER IN SITU KERATOMILEUSIS. PURPOSE: TO COMPARE THE ASTIGMATIC CORRECTION IN HIGH MYOPIC ASTIGMATISM BETWEEN SMALL-INCISION LENTICULE EXTRACTION AND LASER IN SITU KERATOMILEUSIS (LASIK) USING VECTOR ANALYSIS. SETTING: (B)(6) LASER EYE CENTER, (B)(6).DESIGN: RETROSPECTIVE CASE SERIES. METHODS: PATIENTS WHO HAD CORRECTION OF MYOPIC ASTIGMATISM OF 3.0 DIOPTERS (D) OR MORE AND HAD EITHER SMALL-INCISION LENTICULE EXTRACTION OR FEMTOSECOND LASER¿ASSISTED LASIK WERE INCLUDED. ONLY THE LEFT EYE WAS INCLUDED FOR ANALYSIS. VISUAL AND REFRACTIVE RESULTS WERE PRESENTED AND COMPARED BETWEEN GROUPS. RESULTS: THE STUDY COMPRISED 105 PATIENTS (40 EYES IN THE SMALL-INCISION LENTICULE EXTRACTION GROUP AND 65 EYES IN THE FEMTOSECOND LASER¿ASSISTED LASIK GROUP). THE MEAN PREOPERATIVE MANIFEST CYLINDER WAS 3.42 D G 0.55 (SD) IN THE SMALL-INCISION LENTICULE EXTRACTION GROUP AND 3.47 G 0.49 D IN THE LASIK GROUP (P Z .655). AT 3 MONTHS, THERE WAS NO SIGNIFICANT BETWEEN-GROUP DIFFERENCE IN UNCORRECTED DISTANCE VISUAL ACUITY (P Z .915) AND MANIFEST SPHERICAL EQUIVALENT (P Z .145). NINETY PERCENT AND 95.4% OF EYES WERE WITHIN G 0.5 D OF THE ATTEMPTED CYLINDRICAL CORRECTION FOR THE SMALL INCISION LENTICULE EXTRACTION AND LASIK GROUP, RESPECTIVELY (P Z .423). VECTOR ANALYSIS SHOWED COMPARABLE TARGET-INDUCED ASTIGMATISM (P Z .709), SURGICALLY INDUCED ASTIGMATISM VECTOR (P Z .449), DIFFERENCE VECTOR (P Z .335), AND MAGNITUDE OF ERROR (P Z .413) BETWEEN GROUPS. THE ABSOLUTE ANGLE OF ERROR WAS 1.88 G 2.25 DEGREES IN THE SMALL-INCISION LENTICULE EXTRACTION GROUP AND 1.37 G 1.58 DEGREES IN THE LASIK GROUP (P Z .217). CONCLUSION: SMALL-INCISION LENTICULE EXTRACTION OFFERED ASTIGMATIC CORRECTION COMPARABLE TO LASIK IN EYES WITH HIGH MYOPIC ASTIGMATISM. NOTE: 3 EYES LOST ONE OR MORE LINES OF CORRECTED DISTANCE VISUAL ACUITY (CDVA).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718672 INTRALASE FEMTOSECOND LASER HNO JOHNSON & JOHNSON SURGICAL VISION, INC. 20005J

    Patients

    Seq Age Sex Outcome Treatment
    1 Other