BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARGUS II RETINAL PROSTHESIS

    MDR report key: 7304550 · Received February 28, 2018

    Report

    Report Number
    3004081696-2018-00003
    Event Type
    Injury
    Date Received
    February 28, 2018
    Date of Event
    January 29, 2018
    Report Date
    January 29, 2018
    Manufacturer
    SECOND SIGHT MEDICAL PRODUCTS, INC.
    Product Code
    NBF
    PMA / PMN Number
    H110002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    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, THIS PATIENT WAS DIAGNOSED WITH CONJUNCTIVAL DEHISCENCE IN THE IMPLANTED EYE. INTRAOCULAR PRESSURE (IOP) IN THE IMPLANTED EYE WAS 21 MMHG. THE SURGEON CLOSED THE CONJUNCTIVAL DEHISCENCE WITH ADDITIONAL SUTURES. ON (B)(6) 2018, RECURRENT CONJUNCTIVAL DEHISCENCE WAS OBSERVED IN THE IMPLANTED EYE AND IOP IN THE IMPLANTED EYE WAS 30 MMHG. PATIENT HAD BEEN ON PRESCRIBED GLAUCOMA EYE DROPS SINCE (B)(6) 2018. ON (B)(6) 2018, CONJUNCTIVAL AUTOGRAFT HARVESTED FROM THE FELLOW EYE WAS SUTURED OVER THE CONJUNCTIVAL DEHISCENCE IN THE IMPLANTED EYE. ON (B)(6) 2018, THE SURGEON REPORTED THAT THE PATIENT'S CONJUNCTIVA WAS FULLY CLOSED AND IOP IN THE IMPLANTED EYE WAS 16 MMHG. PATIENT IS CONTINUING THE PRESCRIBED EYE DROPS. THERE WAS NO DEFECT OR MALFUNCTION OF THE DEVICE ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145673 ARGUS II RETINAL PROSTHESIS RETINAL PROSTHESIS NBF SECOND SIGHT MEDICAL PRODUCTS, INC. 011015-001 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention