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 2017-08-04 for ARGUS II RETINAL PROSTHESIS 011013-001-K 011013 manufactured by Second Sight Medical Products, Inc..
[81899318]
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
[81899319]
This patient was implanted with an argus ii device on (b)(6) 2012. On (b)(6) 2017, this patient was diagnosed with rubeosis iridis and hypotony in the implanted eye. On (b)(6) 2017, the patient received an intravitreal and an intracameral injection of avastin. The patient was followed up at the hospital and clinic at regular intervals following the injection. On (b)(6) 2017, the surgeon reported that patient had a soft eye, and decided to repeat the avastin injection. On (b)(6) 2017, the patient received a second dose of an intravitreal and an intracameral injection of avastin. On (b)(6) 2017, intraocular pressure in the patient's implanted eye was 9 mmhg. There was no defect or malfunction of the device associated with this event.
Patient Sequence No: 1, Text Type: D, B5
[117744417]
This event represents a follow-up report to mdr# 3004081696-2017-00011. 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
[117744418]
This (b)(6) patient was diagnosed with rubeosis iridis and hypotony in the implanted eye and received an intravitreal and an intracameral injection of avastin on (b)(6) 2017, (b)(6) 2017, and (b)(6) 2017. New information: the intraocular pressure (iop) in the patient's implanted eye was 9 mmhg and 6 mmhg on (b)(6) 2018 and (b)(6) 2018, respectively. Patient was hospitalized on (b)(6) 2018 and received an injection of avastin and healon in the anterior chamber. Patient was discharged on (b)(6) 2018. Patient's iop was reported to be 8 mmhg on (b)(6) 2018. There was no defect or malfunction of the device associated with this event.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 3004081696-2017-00011 |
MDR Report Key | 6769040 |
Report Source | FOREIGN,HEALTH PROFESSIONAL,S |
Date Received | 2017-08-04 |
Date of Report | 2018-12-06 |
Date of Event | 2018-12-05 |
Date Mfgr Received | 2018-12-06 |
Device Manufacturer Date | 2011-06-13 |
Date Added to Maude | 2017-08-04 |
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. PUNITA CHRISTOPHER, PHD |
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 |
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 | 2017-08-04 |
Model Number | 011013-001-K |
Catalog Number | 011013 |
Lot Number | N/A |
Device Expiration Date | 2013-06-13 |
Operator | HEALTH PROFESSIONAL |
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 | 2017-08-04 |