IC-8 Apthera Intraocular Lens (IOL) - P210005
This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: IC-8 Apthera Intraocular Lens (IOL)
PMA Applicant: AcuFocus, Inc.
Address: 32 Discovery, Suite 200, Irvine, CA 92618 USA
Approval Date: July 22, 2022
Approval Letter: Approval order
What is it?
The IC-8 Apthera Intraocular Lens (IOL) is an artificial lens implanted in the eye of adult patients. The lens is intended to provide vision correction after the eye’s natural lens is removed because it has become cloudy (cataract).
How does it work?
The IC-8 Apthera IOL works by bending light rays to allow them to focus on the back surface of the eye (retina). The IC-8 Apthera lens is an extended depth of focus intraocular lens. It focuses light through a small hole (pinhole optics) in the lens which allows the user to focus on objects close up (intermediate and near vision) while maintaining the ability to focus on objects far away (distance vision), which is the intended purpose of standard (monofocal) IOLs.
When is it used?
The IC-8 Apthera IOL is used in adults who have cataracts, need eye surgery, and have only a small amount (1.5 diopters or less) of abnormal curve to the cornea (astigmatism). It is implanted in the non-dominant eye only after the dominant eye has undergone successful implantation of a monofocal or monofocal toric intraocular lens targeted for distance vision (emmetropia).
What will it accomplish?
The IC-8 Apthera IOL improves near and intermediate vision compared to conventional monofocal lenses that provide improved vision at far distances only.
The safety and effectiveness of the IC-8 Apthera IOL was studied in a non-randomized, controlled, clinical trial. In that study, 453 people had intraocular lenses implanted in both eyes. One group, the treatment group, received the IC-8 Apthera in one eye and a monofocal control intraocular lens in the other. The control group received monofocal intraocular lenses in both eyes.
At 6 months after surgery, people who received IC-8 Apthera reported better near and intermediate visual acuity and comparable distance vision to the control group. On average, IC-8 Apthera users achieved improved vision when using both eyes (binocular vision) at intermediate distance (20/22 or 0.051 logMAR) and near distance (20/31 or 0.228 logMAR), compared to the control group’s intermediate (20/34 or 0.186 logMAR) and near (20/48 or 0.1576 logMAR) vision. Both groups achieved 20/20 (0.0 logMAR) binocular visual acuity for far distance.
When should it not be used?
The IC-8 Apthera IOL should not be used in patients if:
- The pupil cannot be dilated with chemicals to at least 7.0 mm.
- There is a history of retinal disease or the patient is predisposed to experiencing retinal disease in the future.