FDA Approves 'Bionic Eye' for Retinitis Pigmentosa Patients

The Argus II Retinal Prosthesis System, called a "bionic eye" by some, has become the first FDA-approved implanted device to improve vision loss due to advanced retinitis pigmentosa.

The device uses a combination of electrodes in the retinal that receive wireless transmissions from a specialized video camera mounted on a pair of glasses to enable adults who have lost most or all of their vision to detect light and dark in the environment.

Clinical studies reviewed by the FDA showed the device helped otherwise blind subjects perform simple tasks such as matching gray-toned socks or detecting street curbs, with 19 of 30 subjects experiencing no adverse side effects. However, 11 participants experienced serious side effects including erosion of the conjunctiva, retinal detachment and hypotony, according to the report.

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