BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAR

    MDR report key: 8639907 · Received May 24, 2019

    Report

    Report Number
    3006695864-2019-00421
    Event Type
    Injury
    Date Received
    May 24, 2019
    Date of Event
    May 1, 2019
    Report Date
    November 12, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    LZS
    UDI-DI
    00(01)(21)3301
    PMA / PMN Number
    P930016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    IN INITIAL REPORT, THE MANUFACTURER YEAR WAS ONLY PROVIDED, HOWEVER THE FULL DATE IS 3/5/1998. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC HAS BEEN SUBMITTED.

    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

    MANUFACTURER YEAR: 1998. (B)(4). 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. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LASER VISION CORRECTION PATIENT HAD SURGERY ON (B)(6) 2007 AND PRESENTED ON (B)(6) 2019 WITH BLURRY VISION AND IRREGULAR ASTIGMATISM IN THE (OD) RIGHT EYE. THE PATIENT IS BEING EVALUATED FOR ENHANCEMENT. IT WAS STATED THAT THE PATIENT HAD LOSS OF BEST CORRECTED VISUAL ACUITY (BCVA). PATIENT REPORTED SYMPTOMS ARE NOT INTERFERING WITH DAILY ACTIVITIES. THE BCVA ON (B)(6) 2019 WAS 20/40 ON THE RIGHT EYE. A MICROKERATOME WAS USED FOR FLAP. PRE-OP BCVA FROM (B)(6) 2007. RIGHT EYE POST-OP 20/20 -6.25 X -1.25 X 22. LEFT EYE POST-OP 20/20 -6.25 X -.25 X 109.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434509 STAR EXCIMER LASER LZS JOHNSON & JOHNSON SURGICAL VISION, INC. 0030-1479 00(01)(21)3301

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other