BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAR

    MDR report key: 8283593 · Received January 28, 2019

    Report

    Report Number
    3006695864-2019-00065
    Event Type
    Injury
    Date Received
    January 28, 2019
    Date of Event
    December 23, 2018
    Report Date
    November 6, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    LZS
    UDI-DI
    00(01)(21)3129
    PMA / PMN Number
    P930016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURING SITE REPORTED THAT THE MANUFACTURING DATE FOR THE DEVICE IS 2/24/1996.

    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

    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) 2018 AND PRESENTED ON (B)(6) 2018 WITH AN ABRASION AND PAIN IN LEFT EYE. THE TOPICAL STEROID DOSAGE WAS INCREASED. IT WAS STATED THAT THE PATIENT HAD NO LOSS OF BEST CORRECTED VISUAL ACUITY (BCVA). THE PATIENT COMPLAINED OF PAIN IN LEFT EYE. PATIENT REPORTED SYMPTOMS ARE NOT INTERFERING WITH DAILY ACTIVITIES AND RESOLVED ON (B)(6) 2018. BCVA FROM (B)(6) 2018: RIGHT EYE PRE-OP 20/20 -.50 X -1.25 X 14, LEFT EYE PRE-OP 20/20 .25 -.75 X 166. THIS REPORT IS FOR THE VISX LASER. A SEPARATE REPORT IS BEING SUBMITTED FOR THE INTRALASE LASER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76706 STAR EXCIMER LASER LZS JOHNSON & JOHNSON SURGICAL VISION, INC. 0030-1479 00(01)(21)3129

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention INTRALASE 0907-40376