IC-8 Apthera Intraocular Lens (IOL)
FDA premarket approval P210005 · decided 2022-07-22
Approval details
- PMA number
- P210005
- Trade name
- IC-8 Apthera Intraocular Lens (IOL)
- Generic name
- Extended depth of focus intraocular lens
- Applicant
- Acu Focus, Inc.
- Date received
- 2021-02-24
- Decision date
- 2022-07-22
- Days to decision
- 513 days
- Decision code
- APPR
- Product code
- POE
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- 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-
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