A Clinical Investigation of the ClarVista HARMONI(Trademark) Modular Intraocular Lens Implant during Cataract Surgery

The surgery involves the implantation of an artificial lens inside the eye that replaces the focusing power of the natural lens that has surgically removed as part of cataract surgery. The study device (HARMONI MODULAR Intraocular Lens Implant System) includes a base component and an optic component which allows optic exchange after the primary surgical procedure. A standard implant is a single piece (no components). This implantation of the study device occurs in one eye while the other eye receives a commercially available artificial lens. The primary implantation procedure takes about 5 minutes but the entire cataract procedure takes about 30 minutes, typically performed under topical or local anesthesia by an ophthalmic surgeon. An optic exchange may be performed 3 months after the primary surgery to adjust the subject's visual function. This procedure takes about 15 minutes under the same anesthetic method and also performed by an ophthalmic surgeon. The implant package label will be collected on the CRF.