Ophthalmic Devices Panel of the Medical Devices Advisory Committee Meeting

Ophthalmic Devices Panel of the Medical Devices Advisory Committee Meeting Committee Meeting April 8, 2013 8:00 a.m. - 6:00 p.m. Agenda: On April 8, 2013, the committee will discuss, make recommendations, and vote on information regarding the premarket approval application for the Trulign Toric posterior chamber intraocular lens sponsored by Bausch and Lomb. The Trulign Toric posterior chamber intraocular lens is intended for primary implantation in the capsular bag of the eye for visual correction of aphakia and postoperative refractive astigmatism secondary to removal of a cataractous lens in adult patients with or without presbyopia, who desire improved uncorrected distance vision and reduction of residual refractive cylinder. Trulign Toric provides approximately one diopter of monocular accommodation, which allows for near, intermediate, and distance vision without spectacles.