BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 8561379 · Received April 29, 2019

    Report

    Report Number
    3006695864-2019-00342
    Event Type
    Injury
    Date Received
    April 29, 2019
    Date of Event
    April 2, 2019
    Report Date
    November 11, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    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 (B)(4) 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 CORNEAL EDEMA WITH (IOP) INCREASED INTRAOCULAR PRESSURE ON (OU) BOTH EYES. IOP MEASUREMENTS: IOP 45 (OD) RIGHT EYE, 51 (OS) LEFT EYE. THE PATIENT WAS TREATED WITH PRED FORTE ON THE OD BUT WAS DISCONTINUED AFTER 21 DAYS OF USE. THE NEW TREATMENT PLAN WAS TIMOLOL VIALS GIVEN TWICE A DAY (BID) IN OU. MURO FOUR TIMES A DAY (QID) OU. LUMIFY DROPS PLACED IN OFFICE OU AND WILL FOLLOW CLOSELY. IT WAS STATED THAT THE PATIENT HAD NO LOSS OF BEST CORRECTED VISUAL ACUITY (BCVA). THE PATIENT COMPLAINED OF BLURRY VISION ON BOTH EYES PAST FIVE DAYS. PATIENT REPORTED SYMPTOMS ARE NOT INTERFERING WITH DAILY ACTIVITIES. PRE-OP BCVA FROM (B)(6) 2019: RIGHT EYE POST-OP 20/20 -2.75 X -.75 X 102. LEFT EYE POST-OP 20/20 -2.75 X -.00 X 90.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355119 INTRALASE FS2 FEMTOSECOND LASER HNO JOHNSON & JOHNSON SURGICAL VISION, INC. 20003D

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention WAVELIGHT S/N: (B)(6) | WAVELIGHT S/N: (B)(4)