BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRALASE FS2

    MDR report key: 9531003 · Received December 30, 2019

    Report

    Report Number
    3006695864-2019-01018
    Event Type
    Malfunction
    Date Received
    December 30, 2019
    Date of Event
    December 3, 2019
    Report Date
    November 5, 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

    H4. DEVICE MANUFACTURE DATE (MM/DD/YYYY) CHANGED TO 2/24/1996. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC HAS BEEN SUBMITTED. H3 OTHER TEXT : PLACEHOLDER.

    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)(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) 2019 AND PRESENTED ON (B)(6) 2019 WITH EPITHELIAL INGROWTH AND BLURRED VISION IN PATIENT'S LEFT EYE (OS). PATIENT'S CHIEF COMPLAINT WAS OF BLURRY VISION. IT WAS STATED THAT THE PATIENT HAD A LOSS OF BEST CORRECTED VISUAL ACUITY (BCVA). THE PATIENT REPORTED THE SYMPTOMS ARE NOT INTERFERING WITH DAILY ACTIVITIES. SECONDARY SURGICAL INTERVENTION WAS REQUIRED. BCVA FROM (B)(6) 2019, RIGHT EYE PRE-OP WAS 20/20 -.75 X -1.00 X 25 AND LEFT EYE PRE-OP WAS 20/20 -1.00 X -.50 X 155. BCVA FROM (B)(6) 2019, LEFT EYE POST-OP WAS 20/25 .75 X -1.75 X 123. THIS REPORT IS FOR THE VISX LASER. A SEPARATE REPORT WILL BE FILED FOR THE FEMTO LASER EQUIPMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1327640 INTRALASE FS2 EXCIMER LASER LZS JOHNSON & JOHNSON SURGICAL VISION, INC. 0030-1479 00(01)(21)3129

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Required Intervention INTRALASE 0907-40376