BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARGUS II RETINAL PROSTHESIS

    MDR report key: 7683145 · Received July 12, 2018

    Report

    Report Number
    3004081696-2018-00007
    Event Type
    Injury
    Date Received
    July 12, 2018
    Date of Event
    May 17, 2018
    Report Date
    July 1, 2018
    Manufacturer
    SECOND SIGHT MEDICAL PRODUCTS, INC.
    Product Code
    NBF
    PMA / PMN Number
    H110002
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL PERTINENT INFORMATION AVAILABLE TO SECOND SIGHT MEDICAL PRODUCTS, INC. HAS BEEN SUBMITTED. THE COMPANY IS SUBMITTING THIS MDR TO ENSURE FULL COMPLIANCE WITH 21 CFR PART 803.

    Description of Event or Problem · 1

    THIS PATIENT WAS IMPLANTED WITH THE ARGUS II DEVICE ON (B)(6) 2018. ON (B)(6) 2018, THE PATIENT WAS DIAGNOSED WITH A VITREOUS HEMORRHAGE, ELEVATED INTRAOCULAR PRESSURE (IOP), AND HYPHEMA IN THE IMPLANTED EYE. THE PATIENT WAS PRESCRIBED MEDICATION TO TREAT THE ELEVATED IOP. ON (B)(6) 2018, THE PATIENT UNDERWENT PARS PLANA VITRECTOMY WITH A SILICONE OIL TAMPONADE. PATIENT'S VITREOUS HEMORRHAGE AND ELEVATED IOP WERE CONSIDERED RESOLVED ON (B)(6) 2018, RESPECTIVELY. THE HYPHEMA CONTINUES TO IMPROVE. THERE WAS NO DEFECT OR MALFUNCTION OF THE DEVICE ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524493 ARGUS II RETINAL PROSTHESIS RETINAL PROSTHESIS NBF SECOND SIGHT MEDICAL PRODUCTS, INC. 011016-002-K N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention