Clareon Vivity Extended Vision Hydrophobic Intraocular Lens (IOL), Clareon Vivity Toric Extended Vision Hydrophobic IO
FDA premarket approval P190018/S013 · decided 2022-01-26
Approval details
- PMA number
- P190018
- Supplement
- S013
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Clareon Vivity Extended Vision Hydrophobic Intraocular Lens (IOL), Clareon Vivity Toric Extended Vision Hydrophobic IO
- Generic name
- Extended depth of focus intraocular lens
- Applicant
- Alcon Laboratories, LLC
- Date received
- 2021-10-29
- Decision date
- 2022-01-26
- Days to decision
- 89 days
- Decision code
- APPR
- Product code
- POE
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- Approval for the Clareon Vivity Extended Vision Hydrophobic IOL and the Clareon Vivity Toric Extended Vision Hydrophobic IOL in lens case and AutonoMe Automated Pre-loaded Delivery System configurations.
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