Extended Depth Of Focus Intraocular Lens
Basic Information
- Device Name
- Extended Depth Of Focus Intraocular Lens
- Trade Name
- IC-8 Apthera Intraocular Lens (IOL)
- PMA Number
- P210005
- Device Class
- FDA Class 3
- Product Code
- POE
- Generic Name
- Extended depth of focus intraocular lens
- Regulation Number
- 886.3600
- Medical Specialty
- Ophthalmic
- Advisory Committee
- Ophthalmic
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- July 22, 2022
- Date Received
- February 24, 2021
- Expedited Review
- N
- Docket Number
- 22M-1672
Advisory Committee Statement
Approval for the IC-8 Apthera IOL. The device is indicated for unilateral implantation for the visual correction of aphakia and to create monovision in patients of age 22 or older who have been diagnosed with bilateral operable cataract, who have up to 1.5 D of astigmatism in the implanted eye, and who do not have a history of retinal disease and who are not predisposed to experiencing retinal disease in the future. The device is intended for primary implantation in the capsular bag, in the non-dominant eye, after the fellow eye has already undergone successful implantation (uncorrected distance visual acuity 20/32 or better and best-corrected distance visual acuity 20/25 or better) of a monofocal or monofocal toric IOL that is targeted for emmetropia. The refractive target for the IC-8 Apthera IOL should be -0.75 D. The lens mitigates the effects of presbyopia by providing an extended depth of focus. Compared to an aspheric monofocal or monofocal toric IOL, the lens provides improved intermediate and near visual acuity, while maintaining comparable distance visual acuity.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| POE | Extended Depth Of Focus Intraocular Lens | FDA class 3 | Ophthalmic |