AcuFocus Intraocular Lens Gets 510(k) Clearance for Cataracts

The FDA granted 510(k) clearance to AcuFocus for its IC-8 Apthera intraocular lens for treatment of cataracts.

The IC-8 Apthera lens features the company’s proprietary small aperture technology, which allows for better distance, intermediate and near vision.

The clearance was based on data from an Investigational Device Exemption study in which the device produced statistically superior intermediate and near vision compared to control subjects.

AcuFocus plans a limited commercial release of the product this fall.