BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAR

    MDR report key: 8211867 · Received January 3, 2019

    Report

    Report Number
    3006695864-2019-00002
    Event Type
    Injury
    Date Received
    January 3, 2019
    Date of Event
    November 7, 2018
    Report Date
    November 6, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    LZS
    UDI-DI
    00(01)(21)5400
    PMA / PMN Number
    P930016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE MANUFACTURE DATE CORRECTED TO 07/09/1996 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

    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 NON SPECIFIC/IDIOPATHIC STERILE INFILTRATES IN BOTH EYES (OU). UNCORRECTED VISUAL ACUITY (UCVA) WAS 20/15 ON BOTH EYES (OU) IT WAS STATED THAT THE PATIENT HAD NO LOSS OF BEST CORRECTED VISUAL ACUITY (BCVA). NO COMPLAINTS FROM THE PATIENT. THE PATIENT REPORTED THE SYMPTOMS ARE NOT INTERFERING WITH DAILY ACTIVITIES. TOPICAL STEROID DOSAGE WAS INCREASED. BCVA FROM (B)(6) 2018, RIGHT EYE PRE-OP 20/20 -1.25 X -1.25 X 1; LEFT EYE PRE-OP 20/25 -1.25 X -.75 X 176. BCVA FROM (B)(6) 2018, RIGHT EYE POST-OP 20/20 .50 X -.25 X 27; LEFT EYE POST-OP 20/20 .75 X -.25 X 99. THIS REPORT IS FOR THE EXCIMER LASER EQUIPMENT. A SEPARATE REPORT WILL BE SUBMITTED FOR THE FEMTO LASER EQUIPMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5530 STAR EXCIMER LASER LZS JOHNSON & JOHNSON SURGICAL VISION, INC. 0030-2450 00(01)(21)5400

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention FEMTO LASER (B)(4)| FEMTO LASER (B)(4)