BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IFS

    MDR report key: 7548018 · Received May 29, 2018

    Report

    Report Number
    3006695864-2018-01228
    Event Type
    Injury
    Date Received
    May 29, 2018
    Date of Event
    May 1, 2018
    Report Date
    May 28, 2018
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC
    Product Code
    HNO
    UDI-DI
    05050474573468
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF RECORDS RELATED TO THE DEVICE INCLUDING 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 TRANSIENT LIGHT SENSITIVITY IN BOTH EYES(OU) POST TREATMENT. IT WAS STATED THAT THE PATIENT HAD NO A LOSS OF BEST CORRECTED VISUAL ACUITY (BCVA). THE SURGERY CENTER NOTED THE PATIENT STATED THERE WAS SIGNIFICANT LIGHT SENSITIVITY THAT BEGAN WHEN PRED-GATI (PREDNISOLONE ACETATE AND GATIFLOXACIN WAS DISCONTINUED). THE PATIENT STATED THAT ITS DIFFICULT TO WORK ON COMPUTER DUE TO BRIGHTNESS BUT VISION IS GOOD. TOPICAL STEROID DOSAGE WAS INCREASED TO BE TAPERED OFF. THE PATIENT REPORTED THE SYMPTOMS ARE NOT INTERFERING WITH DAILY ACTIVITIES. BCVA FROM (B)(6) 2018: RIGHT EYE PRE-OP 20/20 -9.00 X -.25 X 15; LEFT EYE PRE-OP 20/20 -7.25 X -.50 X 155.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393210 IFS FEMTOSECOND LASER HNO JOHNSON & JOHNSON SURGICAL VISION, INC J20007D 05050474573468

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Required Intervention WAVELIGHT SERIAL NO.(B)(4)