Safety concerns may stymie FDA approval for 1st-of-its-kind retinal prosthesis

September 27, 2012 by MassDevice staff

The FDA's Ophthalmic Devices Panel will convene tomorrow to review Second Sight's Argus II retinal prosthesis for the blind, but a high rate of revision surgeries and the device's potential for long-term safety risks may prevent the novel device from reaching the market.

Second Sight's Argus II retinal prosthesis

The FDA's Ophthalmic Devices Panel will convene tomorrow to discuss potential approval for Second Sight Medical Products' Argus II retinal prosthesis for the blind.

The "bionic eye," which uses a head-worn camera to capture a scene and process it into electrical signals that are then sent to the cells in the eye, may pose long-term risk that increase over time, according to panel documents released ahead of the meeting.

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