BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 9480860 · Received December 17, 2019

    Report

    Report Number
    3006695864-2019-01003
    Event Type
    Injury
    Date Received
    December 17, 2019
    Date of Event
    November 18, 2019
    Report Date
    November 4, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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

    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

    HOLD FOR FS IT WAS REPORTED THAT A LASER VISION CORRECTION PATIENT HAD SURGERY ON (B)(6) 2019 AND PRESENTED ON (B)(6) 2019 WITH INFECTIVE BACTERIAL CONJUNCTIVITIS (INJ CONJ). IT WAS NOTED THERE WAS NO MUCUS DISCHARGE, NO PAIN AND THE CORNEAS WERE CLEAR. THE PATIENT'S CHIEF COMPLAINT WAS OF REDNESS AND DISCOMFORT BUT FEELING MUCH BETTER AS OF (B)(6) 2019 AND HAD IMPROVED. AT FOLLOW UP EXAM, THE ANTERIOR CHAMBER ON BOTH EYES WERE TO BE TREATED WITH A COMBINATION OF ANTIBIOTICS FOR ONCE A DAY. AT A 24 RECHECK EXAM, THE LEFT EYE HAD IMPROVED FROM STAGE 3+ INFECTIVE CONJUNCTIVITIS TO STAGE 1+. THE PATIENT WAS TO CONTINUE WITH TREATMENT TO BE SLOWLY TAPER. BCVA FROM (B)(6) 2019: RIGHT EYE PRE-OP 20/20 -2.50 X -.25 X 47, LEFT EYE PRE-OP 20/20 -2.50 X .00 X 90. BCVA FROM (B)(6) 2019: RIGHT EYE POST-OP 20/25 .00 X -.00 X 90, LEFT EYE POST-OP 20/25 .00 X .00 X 90.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1276308 INTRALASE FS2 FEMTOSECOND LASER HNO JOHNSON & JOHNSON SURGICAL VISION, INC. 20003D

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention WAVELIGHT (B)(6)