Posterior-chamber intraocular lens, pseudophakic, extended-focus

Intended purpose

The IC-8 (Hydrophobic Small Aperture Intraocular Lens) (HP-SA-IOL) is intended for primary implantation for the visual correction of aphakia secondary to removal of a cataractous lens in adult patients with or without presbyopia, who desire near, intermediate and far vision with increased spectacle independence. The lens is intended for implantation in the capsular bag. The IC-8 IOL Injection System is used for implanting the IC-8 IOL into the eye following cataract removal. The System provides a controlled means to accurately place the lens into the capsular bag. The IC-8 IOL Injection System consists of two parts: a sterile single-use cartridge and a sterile single-use injector. The IC-8 IOL Injection System is manufactured from medical grade polycarbonate and polypropylene materials.