N
Patient 1
ALL PERTINENT INFORMATION AVAILABLE TO (B)(4). HAS BEEN SUBMITTED. THE COMPANY IS SUBMITTING THIS MDR TO ENSURE FULL COMPLIANCE WITH 21 CFR PART 803.
MAUDE MDR 6430448
- MDR report key
- 6430448
- Report number
- 3004081696-2017-00006
- Event key
- 0
- Event type
- 3
- Date of event
- 2017-02-22
- Date received
- 2017-03-23
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MR. MARK LOAR
- Address
- 12744 SAN FERNANDO RD. SUITE 400 SYLMAR CA 91342 US
- Phone
- 818-818-8188
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | ARGUS II RETINAL PROSTHESIS | RETINAL PROSTHESIS | SECOND SIGHT MEDICAL PRODUCTS, INC. | NBF | 011014-004-K | 011014 | N/A | N | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-03-23 | 0 | 1. R |
Event Narratives#
D
Patient 1
THIS PATIENT WAS IMPLANTED WITH THE ARGUS II DEVICE ON (B)(6) 2016. ON (B)(6) 2017, THE PATIENT REPORTED TEARING AND A FEELING OF MILD TENDERNESS IN THE IMPLANTED EYE. THE PATIENT REPORTED ACCIDENTALLY POKING THE IMPLANTED EYE IN (B)(6) 2016, AFTER WHICH THE EYE APPEARED RED. INTRAOCULAR PRESSURE (IOP) IN THE IMPLANTED (LEFT) EYE WAS 0 MMHG. A FLUOROSCEIN STRIP TEST SHOWED NO LEAKAGE IN THE IMPLANTED EYE. THE PATIENT WAS INSTRUCTED TO NOT TOUCH THE IMPLANTED EYE AND ORBITAL AREA. ON (B)(6) 2017, PATIENT CAME IN FOR A FOLLOW-UP VISIT, AND REPORTED FLUID DISCHARGE IN THE IMPLANTED EYE. IOP WAS 1 MMHG. THE SURGEON REPORTED THAT THE IMPLANT CABLE WAS EXPOSED AND THE SUTURE WAS IN PLACE ON THE DEVICE, BUT CAME LOOSE FROM THE SCLERA. PATIENT UNDERWENT REVISION SURGERY DURING WHICH THE IMPLANT WAS RE-SUTURED TO THE SCLERA, AND THE EXPOSED IMPLANT WAS COVERED WITH PERICARDIUM GRAFT. ON (B)(6) 2017, THE IOP WAS STILL LOW (NOT MEASURABLE). THE SURGEON REPORTED THAT THERE WAS NO LEAKAGE, THE CORNEA APPEARED CLEAR, AND THERE WERE NO SIGNS OF INFECTION. THERE WAS NO DEFECT OR MALFUNCTION OF THE DEVICE ASSOCIATED WITH THIS EVENT.
N
Patient 1
THIS EVENT REPRESENTS A FOLLOW-UP REPORT TO MDR# 3004081696-2017-00006. ALL PERTINENT INFORMATION AVAILABLE TO SECOND SIGHT (B)(4). HAS BEEN SUBMITTED. THE COMPANY IS SUBMITTING THIS MDR TO ENSURE FULL COMPLIANCE WITH 21 CFR PART 803.
D
Patient 1
THIS PATIENT EXPERIENCED HYPOTONY AND CONJUNCTIVAL EROSION IN THE IMPLANTED EYE, AND UNDERWENT REVISION SURGERY ON (B)(6) 2017. NEW INFORMATION: ON (B)(6) 2017, PATIENT HAD LOW INTRAOCULAR PRESSURE (IOP) AND CONJUNCTIVAL EROSION IN THE IMPLANTED EYE. ON (B)(6) 2017, PATIENT UNDERWENT REVISION SURGERY DURING WHICH THE SCLEROTOMY SITE WAS SUTURED CLOSED AND THE IMPLANT WAS RE-SUTURED TO THE SCLERA. THE CABLE AND THE SCLEROTOMY SITE WERE COVERED WITH PERICARDIUM GRAFT. ON (B)(6 2017, IOP IN THE IMPLANTED EYE WAS 6 MMHG, THE WOUND APPEARED SEALED, AND THERE WERE NO SIGNS OF INFECTION. ON (B)(6) 2017, CONJUNCTIVAL EROSION WAS OBSERVED OVER THE ELECTRODE CABLE AND PATIENT'S IOP WAS LOW. A SCLEROTOMY LEAK WAS REPORTED AS WELL. PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2017 DURING WHICH THE SCLEROTOMY WAS SUTURED CLOSED AGAIN, THE IMPLANT WAS RE-SUTURED TO THE SCLERA, A SCLERAL PATCH GRAFT WAS PLACED OVER THE SCLEROTOMY, AND PERICARDIUM WAS PLACED OVER THE IMPLANT AND THE SCLERAL PATCH GRAFT. ON (B)(6) 2017, THE SCLEROTOMY SITE, IMPLANT, AND CABLE WERE WELL COVERED WITH CONJUNCTIVA. ON (B)(6) 2017, THE PATIENT'S IOP WAS 2 MMHG, AND THE SURGEON REPORTED THAT THERE WAS NO CONJUNCTIVAL EROSION OR IMPLANT EXPOSURE. THERE WAS NO DEFECT OR MALFUNCTION OF THE DEVICE ASSOCIATED WITH THIS EVENT.