N
Patient 1
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.
MAUDE MDR 5543509
- MDR report key
- 5543509
- Report number
- 3004081696-2016-00003
- Event key
- 0
- Event type
- 3
- Date of event
- 2016-02-29
- Date received
- 2016-04-03
- 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 | 011014-001-K | 011014 | N/A | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2016-04-03 | 0 | 1. R |
Event Narratives#
D
Patient 1
PATIENT (B)(6) WAS IMPLANTED WITH THE ARGUS II DEVICE ON (B)(6) 2015. THE PATIENT REPORTED PAIN IN THE IMPLANTED EYE SINCE (B)(6) 2016. THE SURGEON NOTED HYPOTONY AND HYPHEMA IN THE IMPLANTED EYE. ON (B)(6) 2016, THE PATIENT UNDERWENT REVISION SURGERY DURING WHICH BLOOD WAS REMOVED FROM THE ANTERIOR CHAMBER OF THE EYE. ANTI-VASCULAR ENDOTHELIAL GROWTH FACTOR DRUGS AS WELL AS ANTIBIOTICS AND GLUCOCORTICOIDS WERE INJECTED INTO THE EYE. IN ADDITION, FIBROTIC TISSUE PRESENT ON THE ANTERIOR AND POSTERIOR SURFACES OF THE INTRAOCULAR LENS WAS REMOVED. THE SURGEON OBSERVED VITREOUS HEMORRHAGE AS WELL AS EXTENSIVE NEOVASCULARIZATION OF THE IRIS, AND LIKELY THE CILIARY BODY REGION. THE ELECTRODE ARRAY OF THE DEVICE WAS IN A GOOD POSITION, THE RETINAL TACK WAS SECURE, AND THE RETINA WAS ATTACHED. NO LEAK IN THE EYE COULD BE FOUND. THE SURGEON REPORTED THAT THE PATIENT'S EYE MAY BE "PREPHTHISICAL." THE PATIENT'S INTRAOCULAR PRESSURE CONTINUES TO BE LOW. THE PATIENT IS ON TOPICAL STEROIDS AND ATROPINE DROPS AND HAS BEEN SCHEDULED FOR ANOTHER REVISION SURGERY ON (B)(6) 2016.
N
Patient 1
THIS EVENT REPRESENTS A FOLLOW-UP REPORT AFTER THE REVISION SURGERY THAT WAS REPORTED IN MDR# 3004081696-2016-00003. 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.
D
Patient 1
THIS PATIENT EXPERIENCED HYPOTONY AND HYPHEMA IN THE IMPLANTED EYE, AND UNDERWENT A REVISION SURGERY ON (B)(6) 2016. DURING SURGERY, THE SURGEON OBSERVED VITREOUS HEMORRHAGE AS WELL AS NEOVASCULARIZATION OF THE IRIS AND CILIARY BODY REGION. NEW INFORMATION: ON (B)(6) 2016, THE SURGEON REPORTED THAT THE NEOVASCULARIZATION HAD REGRESSED, BUT THE VITREOUS HEMORRHAGE AND LOW INTRAOCULAR PRESSURE (IOP) WERE STILL PRESENT. ON (B)(6) 2016, THE PATIENT UNDERWENT A SECOND REVISION SURGERY DURING WHICH A VITRECTOMY AND INJECTION OF SILICONE OIL WERE PERFORMED. ON (B)(6) 2016, THE PATIENT CAME IN FOR A FOLLOW-UP VISIT DURING WHICH IT WAS REPORTED THAT THE PATIENT'S ANTERIOR CHAMBER WAS DEEP, AND THAT THERE WAS NO HYPHEMA OR NEOVASCULARIZATION PRESENT. PATIENT'S IOL WAS REPORTED TO BE IN A GOOD POSITON, VITREOUS WAS CLEAR, AND RETINA WAS ATTACHED. THE ELECTRODE ARRAY WAS IN A GOOD POSITION AS WELL. PATIENT HAS NO PAIN BUT CONTINUES TO HAVE HYPOTONY, AND REMAINS ON PRESCRIBED STEROIDS.