Federal Register Notice: FDA has determined the regulatory review period for Phakic Intraocular Lenses is 2,545 days for extending a patent which claims the medical device. The lenses are indicated for: (1) The reduction or elimination of myopia in adults with myopia ranging from -5 to -20 diopters with less than or equal to 2.5 diopters of astigmatism at the spectacle plane and whose eyes have an anterior chamber depth greater than or equal to 3.2 millimeters; and (2) patients with documented stability of refraction for the prior 6 months, as demonstrated by spherical equivalent change of less than or equal to 0.50 diopters. To view this notice, click here.