MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2016-04-03 for ARGUS II RETINAL PROSTHESIS 011014-001-K 011014 manufactured by Second Sight Medical Products, Inc..
[41715097]
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
[41715098]
Patient (b)(6) was implanted with the argus ii device on (b)(6) 2015. The patient reported pain in the implanted eye since (b)(6) 2016. The surgeon noted hypotony and hyphema in the implanted eye. On (b)(6) 2016, the patient underwent revision surgery during which blood was removed from the anterior chamber of the eye. Anti-vascular endothelial growth factor drugs as well as antibiotics and glucocorticoids were injected into the eye. In addition, fibrotic tissue present on the anterior and posterior surfaces of the intraocular lens was removed. The surgeon observed vitreous hemorrhage as well as extensive neovascularization of the iris, and likely the ciliary body region. The electrode array of the device was in a good position, the retinal tack was secure, and the retina was attached. No leak in the eye could be found. The surgeon reported that the patient's eye may be "prephthisical. " the patient's intraocular pressure continues to be low. The patient is on topical steroids and atropine drops and has been scheduled for another revision surgery on (b)(6) 2016.
Patient Sequence No: 1, Text Type: D, B5
[44474183]
This event represents a follow-up report after the revision surgery that was reported in mdr# 3004081696-2016-00003. 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
[44474184]
This patient experienced hypotony and hyphema in the implanted eye, and underwent a revision surgery on (b)(6) 2016. During surgery, the surgeon observed vitreous hemorrhage as well as neovascularization of the iris and ciliary body region. New information: on (b)(6) 2016, the surgeon reported that the neovascularization had regressed, but the vitreous hemorrhage and low intraocular pressure (iop) were still present. On (b)(6) 2016, the patient underwent a second revision surgery during which a vitrectomy and injection of silicone oil were performed. On (b)(6) 2016, the patient came in for a follow-up visit during which it was reported that the patient's anterior chamber was deep, and that there was no hyphema or neovascularization present. Patient's iol was reported to be in a good positon, vitreous was clear, and retina was attached. The electrode array was in a good position as well. Patient has no pain but continues to have hypotony, and remains on prescribed steroids.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004081696-2016-00003 |
| MDR Report Key | 5543509 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2016-04-03 |
| Date of Report | 2016-03-03 |
| Date of Event | 2016-02-29 |
| Date Mfgr Received | 2016-03-03 |
| Device Manufacturer Date | 2013-07-31 |
| Date Added to Maude | 2016-04-03 |
| 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 | 2016-04-03 |
| Model Number | 011014-001-K |
| Catalog Number | 011014 |
| Lot Number | N/A |
| Device Expiration Date | 2015-07-31 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| 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. Required No Informationntervention | 2016-04-03 |