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 2019-05-24 for ARGUS II RETINAL PROSTHESIS 011016-001 011016 manufactured by Second Sight Medical Products, Inc..
[146215398]
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
[146215399]
This patient was implanted with the argus ii device on (b)(6) 2019. On (b)(6) 2019, this patient was diagnosed with a conjunctival bleb in the implanted eye. Patient was prescribed a medication treatment plan. On (b)(6) 2019, imaging was performed and the patient was diagnosed with a sclerotomy leak. On (b)(6) 2019, patient underwent revision surgery during which the sclerotomy site was sutured closed after replacing a loose sclerotomy suture, a tendon was sutured on top of the sclerotomy, tutopatch was replaced, and gas was injected into the vitreous. On (b)(6) 2019, it was reported that intraocular pressure was 4-5 mmhg and a choroidal detachment was present in the implanted eye. On (b)(6) 2019, the patient underwent a second revision surgery during which a fluid-gas exchange was performed in the implanted eye. There was no defect or malfunction of the device associated with this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004081696-2019-00004 |
| MDR Report Key | 8642450 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2019-05-24 |
| Date of Report | 2019-04-24 |
| Date of Event | 2019-04-22 |
| Date Mfgr Received | 2019-04-24 |
| Device Manufacturer Date | 2018-01-13 |
| Date Added to Maude | 2019-05-24 |
| 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 | DR. PUNITA CHRISTOPHER |
| Manufacturer Street | 12744 SAN FERNANDO RD. SUITE 400 |
| Manufacturer City | SYLMAR CA 91342 |
| Manufacturer Country | US |
| Manufacturer Postal | 91342 |
| Manufacturer Phone | 8188334119 |
| 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 | 2019-05-24 |
| Model Number | 011016-001 |
| Catalog Number | 011016 |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| 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. Required No Informationntervention | 2019-05-24 |