BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 7512993 · Received May 14, 2018

    Report

    Report Number
    3006695864-2018-01065
    Event Type
    Injury
    Date Received
    May 14, 2018
    Date of Event
    April 14, 2018
    Report Date
    May 14, 2018
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 TRACE DIFFUSE LAMELLAR KERATITIS (DLK) IN LEFT EYE. THE TOPICAL STEROID DOSAGE WAS INCREASED, AN ORAL STEROID (MEDROL)WAS PRESCRIBED AND A FLAP LIFT AND RINSE WAS PERFORMED. IT WAS STATED THAT THE PATIENT HAD NO LOSS OF BEST CORRECTED VISUAL ACUITY (BCVA). THE PATIENT HAD NO COMPLAINTS AND MENTIONED IS HAVING GOOD VISION. PATIENT REPORTED SYMPTOMS ARE NOT INTERFERING WITH DAILY ACTIVITIES. BCVA FROM (B)(6) 2018: RIGHT EYE PRE-OP 20/20 -3.50 X .00 X 90, LEFT EYE PRE-OP 20/20 -2.75 X -.75 X 9.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355055 INTRALASE FS2 FEMTOSECOND LASER HNO JOHNSON & JOHNSON SURGICAL VISION, INC 20003D

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Required Intervention