Small-aperture intraocular lens
AcuFocus has received approval for an Investigational Device Exemption (IDE) from the US Food and Drug Administration (FDA) to conduct a study of its IC-8 small-aperture intraocular lens (IOL).
The IC-8 IOL is a clear monofocal lens with an embedded mini-ring or pinhole in the centre. It is designed to increase a patient’s natural range of vision by extending the focus of light rays that enter the eye.
“Achieving IDE approval was the next milestone as we seek premarket approval in the US,” said Al Waterhouse, AcuFocus Chief Executive Officer.