BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIDEK PRIMA KTP LASER SYSTEM

    MDR report key: 271538 · Received March 28, 2000

    Report

    Report Number
    2936921-2000-00001
    Event Type
    Injury
    Date Received
    March 28, 2000
    Date of Event
    January 7, 2000
    Report Date
    March 27, 2000
    Manufacturer
    NIDEK CO. LTD.
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    WHILE USING THE NIDEK GYC-1500 LASER SYSTEM IN TREATING CHOROIDAL NEOVASCULAR MEMBRANES THE PHYSICIAN NOTED HEMORRHAGE AT TIME OF LASER DESPITE INADEQUATE TISSUE RESPONSE ON 01/07/2000 AND 01/21/2000. PT PRESENTED ON 01/28/2000 WITH COMPLAINT OF PAIN, DECREASED VISION FOR LESS THAN 24 HRS. PT WAS FOUND TO HAVE A MASSIVE SUBRETINAL HEMORRHAGE, VITREOUS HEMORRHAGE, ANGLE CLOSURE GLAUCOMA WITH MORBIDLY HIGH INTRA-OCCULAR PRESSURE (IOP). ACCORDING TO THE REPORTING PHYSICIAN, THE PT CONTINUES TO HAVE DECREASED VISION TO HAND MOVEMENT. ALTHOUGH THIS EVENT OCCURRED ON 01/07/2000, NIDEK INC DID NOT BECOME AWARE OF THE INJURY UNTIL 03/16/2000.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NIDEK PRIMA KTP LASER SYSTEM OPHTHALMIC LASER PHOTOCOAGULATOR GEX NIDEK CO. LTD. GYC-1500 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention