Approval Date: February 13, 2013
Approval Letter: http://www.accessdata.fda.gov/ cdrh_docs/pdf11/h110002a.pdf
What is it? The Argus II Retinal Prosthesis System is the first implanted device to treat adults with severe retinitis pigmentosa. The System has three parts: a small electronic device implanted in and around the eye, a tiny video camera attached to a pair of glasses, and a video processing unit that is worn or carried by the patient.
How does it work? The patient wears glasses with an attached video camera that captures images of the surrounding area. These images become an electrical signal which is processed by the video processing unit. The signal is then wirelessly delivered to the eye stimulating the retina. This electrical stimulation of the retina is recognized by the brain as spots of light.
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