BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EC-5000

    MDR report key: 10601717 · Received September 29, 2020

    Report

    Report Number
    0002936921-2020-00003
    Event Type
    Injury
    Date Received
    September 29, 2020
    Date of Event
    May 10, 2017
    Report Date
    September 29, 2020
    Manufacturer
    NIDEK CO. LTD.
    Product Code
    LZS
    PMA / PMN Number
    P970053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    NIDEK INC IS UNABLE TO IDENTIFY THE DEVICE INFORMATION BASED ON THE VOLUNTARY EVENT REPORT #MW5096471, THEREFORE; INVESTIGATION CANNOT BE PERFORMED.

    Description of Event or Problem · 1

    THE PATIENT VOLUNTARILY SUBMITTED REPORT MW5096471 THROUGH THE MEDWATCH PROGRAM TO THE FDA ON SEPTEMBER 8, 2020. FDA FORWARDED THE INFORMATION TO NIDEK INC ON SEPTEMBER 22, 2020 THROUGH MAIL. NIDEK INC BECAME AWARE OF THIS EVENT ON SEPTEMBER 28, 2020. THE PATIENT REPORTED FOLLOWING TO FDA: FOLLOWING A LASIK PROCEDURE WITH THE ZEISS VISUMAX FEMTOSECOND AND NIDEK EC-5000 EXCIMER LASERS, I DEVELOPED PERSISTENT AND CHRONIC DRY EYE, FLOATERS, HALOS, STARBURST, GLARE, AND POOR NIGHT VISION IN BOTH EYES. I DID NOT PREVIOUSLY EXPERIENCE ANY OF THESE ISSUES PRIOR TO SURGERY. MY SURGEON CLAIMS THESE SIDE EFFECTS ARE EXTREMELY RARE AND/OR UNRELATED TO MY SURGERY, CLAIMS THAT OTHER OPHTHALMOLOGISTS HAVE CONFIRMED ARE UNTRUE. CURRENTLY AT ABOUT 3.5 YEARS AFTER SURGERY, THESE SYMPTOMS HAVE ONLY BECOME WORSE WITH TIME. THESE SYMPTOMS HAVE CAUSED PERSISTENT ANXIETY, PAIN, AND DISCOMFORT, ADVERSELY AFFECTING MY EVERYDAY FUNCTION, ABILITY TO WORK, QUALITY OF LIFE, MENTAL HEALTH, AND GENERAL WELL-BEING. ASIDE RECEIVING MEDICAL TREATMENT FOR THESE SYMPTOMS WHICH ARE CHRONIC AND INCURABLE, I ALSO REQUIRE BEHAVIORAL THERAPY TO MAINTAIN MY WELL-BEING. FLOATERS IN BOTH EYES NOTED BY SEVERAL OPHTHALMOLOGISTS, FROM 2018-2019. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1066218 EC-5000 EXCIMER LASER LZS NIDEK CO. LTD. EC-5000

    Patients

    Seq Age Sex Outcome Treatment
    1 Other