MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-06-03 for ARGUS II RETINAL PROSTHESIS 011014-002-K 011014 manufactured by Second Sight Medical Products, Inc..
[46560080]
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
[46560081]
This patient was implanted with the (b)(4) device on (b)(6) 2015. On (b)(6) 2016, patient had a conjunctival erosion in the implanted eye. The patient elected to have the device removed, and on (b)(6) 2016, a partial explant surgery was conducted during which the electrode cable was cut. A small retinal tear was observed in the inferonasal area and was lasered. On (b)(6) 2016, the surgeon reported that the patient was doing well with normal intraocular pressure. The retina was attached and the electrode array was in place. There was no defect or malfunction of the device associated with this event.
Patient Sequence No: 1, Text Type: D, B5
[62415098]
This event represents a follow-up report to mdr #3004081696-2016-00008. Events such as these are sometimes resolved without any surgical intervention. In the case of this patient, no surgery has been scheduled yet. We are, however, reporting this event out of an abundance of caution. 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
[62415099]
This patient experienced conjunctival erosion in the implanted eye, and elected to undergo a partial explant surgery on (b)(6) 2016 during which the electrode cable was cut. New information: on (b)(6) 2016, the patient was diagnosed with a retinal detachment and low intraocular pressure. The patient is on prescribed eye drops including steroid drops. On (b)(6) 2016, it was reported that patient's intraocular pressure was still low. Surgical intervention has been recommended but not yet scheduled. There was no defect or malfunction of the device associated with this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004081696-2016-00008 |
| MDR Report Key | 5699511 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-06-03 |
| Date of Report | 2016-05-06 |
| Date of Event | 2016-05-06 |
| Date Mfgr Received | 2016-05-06 |
| Device Manufacturer Date | 2014-03-04 |
| Date Added to Maude | 2016-06-03 |
| 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 | 2016-06-03 |
| Returned To Mfg | 2016-05-13 |
| Model Number | 011014-002-K |
| Catalog Number | 011014 |
| Lot Number | N/A |
| Device Expiration Date | 2016-03-04 |
| Operator | PHYSICIAN |
| 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. Other; 2. Required No Informationntervention | 2016-06-03 |