{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. 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HAS BEEN SUBMITTED. THE COMPANY IS SUBMITTING THIS MDR TO ENSURE FULL COMPLIANCE WITH 21 CFR PART 803." }, { "mdr_text_key": "195301951", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THIS PATIENT WAS IMPLANTED WITH THE ARGUS II DEVICE ON (B)(6) 2014. ON (B)(6) 2020, PATIENT REPORTED A 2 DAY HISTORY OF REDNESS AND PAIN, AND HAD EXPERIENCED DISCHARGE FROM THE IMPLANTED EYE FOR A MONTH. PATIENT HAD BEEN SEEN IN THE LOCAL EMERGENCY ROOM WHERE SHE WAS PUT ON ANTIBIOTIC EYE DROPS. ON (B)(6) 2020, PATIENT UNDERWENT AN EYE EXAM AND B-SCAN, AND WAS DIAGNOSED WITH A PARTIALLY EXTRUDED ARGUS IMPLANT AND ENDOPHTHALMITIS. PATIENT WAS PRESCRIBED ORAL ANTIBIOTICS. PATIENT WAS SEEN BY THE RETINAL SURGEON ON (B)(6) 2020, AND WAS RECOMMENDED ENUCLEATION OF THE IMPLANTED EYE. ENUCLEATION WAS PERFORMED ON (B)(6) 2020. PATIENT WAS SEEN VIA A VIRTUAL VISIT ON (B)(6) 2020, AND WAS REPORTED TO BE HEALING WELL. 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