OnPoint receives investigational device exemption for pseudophakic capsular lens magnifier

Issue: December 25, 2023

Fact checked byEamon N. Dreisbach

Key takeaways:

OnPoint’s AccuraSee magnifier has been granted investigational device exemption approval by the FDA.
The device is used for secondary implantation with a pre-existing posterior chamber IOL.

OnPoint 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.

Generic FDA News infographic — OnPoint Vision has announced FDA investigational device exemption approval for its AccuraSee device, according to a press release.

The company also announced a third refractive early feasibility study investigational device exemption approval to evaluate the safety and effectiveness of the monofocal IOPCL to improve near or intermediate vision. The monofocal IOPCL was previously studied in patients with low vision.

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OnPoint receives investigational device exemption for pseudophakic capsular lens magnifier

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