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 2017-03-09 for ARGUS II RETINAL PROSTHESIS 011014-003-K 011014 manufactured by Second Sight Medical Products, Inc..
[69522679]
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
[69522680]
This patient was implanted with an argus ii device on (b)(6) 2016. This patient was diagnosed with hypotony in the implanted eye on (b)(6) 2016. On (b)(6) 2017, the patient underwent revision surgery during which intravitreal and anterior chamber healon? Injections were administered in the implanted eye. On (b)(6) 2017, intraocular pressure in the patient's implanted eye was still low. There was no defect or malfunction of the device associated with this event.
Patient Sequence No: 1, Text Type: D, B5
[109697483]
This event represents a follow-up report to mdr# 3004081696-2017-00004. 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
[109697484]
This patient underwent revision surgery on (b)(6) 2017 to address ongoing hypotony. On (b)(6) 2017, this patient was diagnosed with phthisis bulbi following post-operative hypotony and was prescribed analgesics due to ongoing pain. New information: on (b)(6) 2018, a decision was made to explant the device due to ongoing pain and phthisis. On (b)(6) 2018, the extraocular portion of the argus ii device was removed and the electrode array was left tacked to the retina. On (b)(6) 2018, the surgeon reported that the patient was doing fine after explant surgery and was discharged from the hospital. Patient's pain had reduced and intraocular pressure in the explanted eye was 4 mmhg. There was no defect or malfunction of the device associated with this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004081696-2017-00004 |
| MDR Report Key | 6392906 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,S |
| Date Received | 2017-03-09 |
| Date of Report | 2017-02-09 |
| Date of Event | 2017-02-09 |
| Date Mfgr Received | 2017-02-09 |
| Device Manufacturer Date | 2015-02-15 |
| Date Added to Maude | 2017-03-09 |
| 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 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARGUS II RETINAL PROSTHESIS |
| Generic Name | RETINAL PROSTHESIS |
| Product Code | NBF |
| Date Received | 2017-03-09 |
| Model Number | 011014-003-K |
| Catalog Number | 011014 |
| Lot Number | N/A |
| Device Expiration Date | 2017-02-15 |
| 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. Hospitalization; 2. Required No Informationntervention; 3. Deathisabilit | 2017-03-09 |