OnePoint Vision has announced FDA investigational device exemption approval for its AccuraSee device, according to a press release.
The AccuraSee is an intraocular pseudophakic capsular lens (IOPCL) magnifier for secondary implantation in the capsular bag with a pre-existing posterior chamber IOL. The neutral optic magnifies near images when implanted in patients with low-vision pseudophakia and age-related macular degeneration.
The company also announced a third refractive early feasibility study investigational device exemption approval to evaluate the safety and effectiveness of the