MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,s report with the FDA on 2016-04-29 for ARGUS II RETINAL PROSTHESIS 011013-003-K 011013 manufactured by Second Sight Medical Products, Inc..
[44055011]
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.
Patient Sequence No: 1, Text Type: N, H10
[44055012]
This patient was implanted with the argus ii device on (b)(6) 2015. On (b)(6) 2016, the surgeon noted vitreous hemorrhage in the patient's implanted eye. The patient was prescribed anti-inflammatory topical eye drops. On (b)(6) 2016, the patient underwent revision surgery during which a vitreous cavity lavage was performed. Fibrotic tissue and fibrosis membranes were removed from the sclerotomy site. Fibrotic membrane over the electrode array was removed as well. The surgeon observed that the retina was well attached, the choroid and ciliary body were attached, and the electrode array was in place. Antibiotics were injected into the eye. The patient was administered cortisone bolus intravenously for 3 days post-surgery. The patient came in for follow-up visits on (b)(6) 2016. The surgeon noted that the cornea was clear and that there was an improved view to the posterior pole. The patient continues to have low intraocular pressure, and is currently on prescribed corticosteroid eye drops.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004081696-2016-00005 |
| MDR Report Key | 5620318 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,S |
| Date Received | 2016-04-29 |
| Date of Report | 2016-04-01 |
| Date of Event | 2016-03-18 |
| Date Mfgr Received | 2016-04-01 |
| Device Manufacturer Date | 2015-01-31 |
| Date Added to Maude | 2016-04-29 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. MARK LOAR |
| Manufacturer Street | 12744 SAN FERNANDO RD. SUITE 400 |
| Manufacturer City | SYLMAR CA 91342 |
| Manufacturer Country | US |
| Manufacturer Postal | 91342 |
| Manufacturer Phone | 8188335049 |
| Manufacturer G1 | SECOND SIGHT MEDICAL PRODUCTS, INC. |
| Manufacturer Street | 12744 SAN FERNANDO RD. SUITE 400 |
| Manufacturer City | SYLMAR CA 91342 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 91342 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARGUS II RETINAL PROSTHESIS |
| Generic Name | RETINAL PROSTHESIS |
| Product Code | NBF |
| Date Received | 2016-04-29 |
| Model Number | 011013-003-K |
| Catalog Number | 011013 |
| Lot Number | N/A |
| Device Expiration Date | 2017-01-31 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SECOND SIGHT MEDICAL PRODUCTS, INC. |
| Manufacturer Address | 12744 SAN FERNANDO RD. SUITE 400 SYLMAR CA 91342 US 91342 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2016-04-29 |