IC-8 Apthera Intraocular Lens (IOL)
PMA P210005
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP210005 | Date22 Jul 2022 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Generic Name
- Extended depth of focus intraocular lens
- PMA Number
- FDA Product Code
- POE
- Device Class
- Class III
- Regulation
- 21 CFR Part 886.3600
- Advisory Committee
- Ophthalmic
- FDA Decision
- APPR Approved
Overview
AI-generated summary, 18 Sep 2026
The IC-8 Apthera Intraocular Lens (IOL) is an extended depth of focus intraocular lens, classified under the nomenclature for ophthalmic devices. It is designed to correct aphakia through primary implantation in the capsular bag, providing visual correction for patients aged 22 or older with bilateral operable cataract. The lens is engineered to create monovision by mitigating presbyopia effects, offering enhanced intermediate and near visual acuity while maintaining comparable distance vision compared to traditional monofocal or monofocal toric IOLs.
This device is intended for unilateral implantation in the non-dominant eye, following successful monofocal or monofocal toric IOL placement in the fellow eye. It requires a refractive target of -0.75 D and is approved for use in patients with up to 1.5 D of astigmatism in the implanted eye, excluding those with a history or predisposition to retinal disease. Supplied as a sterile, single-use device, it adheres to FDA_PMA authorization under PMA Number P210005 and is categorized under product code POE for regulatory tracking.
Questions
AI-generated answers, 18 Sep 2026
What is the primary purpose of the IC-8 Apthera IOL, and how does it differ from traditional monofocal IOLs?
The IC-8 Apthera IOL is designed to correct aphakia through primary implantation in the capsular bag, specifically for patients aged 22 or older with bilateral operable cataract. Unlike traditional monofocal or monofocal toric IOLs, it creates monovision by extending the depth of focus, which improves intermediate and near visual acuity while maintaining comparable distance vision. This is achieved through its extended depth of focus technology, making it ideal for patients seeking reduced dependence on reading glasses.
How is the IC-8 Apthera IOL intended to be used in combination with other IOLs, and what are the requirements for the fellow eye?
The IC-8 Apthera IOL is intended for unilateral implantation in the non-dominant eye *after* the fellow eye has already received a successful monofocal or monofocal toric IOL. The fellow eye must meet specific visual acuity criteria: uncorrected distance visual acuity of 20/32 or better and best-corrected distance visual acuity of 20/25 or better. This ensures the fellow eye provides clear distance vision, while the IC-8 Apthera IOL enhances intermediate and near vision in the non-dominant eye.
What are the key specifications regarding astigmatism and patient eligibility for the IC-8 Apthera IOL?
The IC-8 Apthera IOL is approved for patients with up to 1.5 diopters (D) of astigmatism in the implanted eye. Additionally, it is intended for patients aged 22 or older who do not have a history of retinal disease and are not predisposed to developing retinal complications. The lens requires a refractive target of -0.75 D during implantation to optimize its extended depth of focus benefits.
Is the IC-8 Apthera IOL a single-use device, and how should it be stored?
Yes, the IC-8 Apthera IOL is supplied as a sterile, single-use device. Since it is sterile upon packaging, it should be stored in its original, unopened packaging to maintain sterility. Avoid exposure to extreme temperatures, moisture, or direct sunlight, and adhere to the manufacturer’s storage guidelines to preserve its integrity until use.
What regulatory pathway does the IC-8 Apthera IOL follow, and how is it categorized?
The IC-8 Apthera IOL follows the FDA Pre-Market Approval (PMA) pathway, authorized under PMA Number P210005. It is classified under the product code POE for regulatory tracking and falls under Class III device classification, as indicated by the FDA’s OpenFDA database. This pathway ensures rigorous evaluation of its safety and effectiveness for its intended use.