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 2019-01-02 for ARGUS II RETINAL PROSTHESIS 011014-003-K 011014 manufactured by Second Sight Medical Products, Inc..
[131889513]
There is no defect or malfunction of the device associated with this event. All pertinent information available to second sight medical products 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
[131889514]
Patient (b)(6) was implanted with the argus ii device on (b)(6) 2017. On (b)(6) 2018, the patient was diagnosed with scleral patch infection and endophthalmitis in the implanted eye. The patient underwent three surgical interventions on (b)(6) 2018, respectively. During the surgical interventions, necrotic tissue and the infected scleral patch were removed. The coil and cable were covered with scleral patches, and the conjunctiva was sutured closed. Patient was administered intraocular antibiotics. There was no defect or malfunction of the device associated with this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004081696-2019-00001 |
| MDR Report Key | 8211178 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,S |
| Date Received | 2019-01-02 |
| Date of Report | 2019-10-18 |
| Date of Event | 2019-10-18 |
| Date Mfgr Received | 2019-10-18 |
| Device Manufacturer Date | 2015-06-02 |
| Date Added to Maude | 2019-01-02 |
| 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 | 2019-01-02 |
| Returned To Mfg | 2019-10-29 |
| Model Number | 011014-003-K |
| Catalog Number | 011014 |
| Lot Number | N/A |
| Device Expiration Date | 2017-06-02 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-01-02 |