Clareon Vivity Extended Vision Hydrophobic Intraocular Lens (IOL), Clareon Vivity Toric Extended Vision Hydrophobic IO
FDA premarket approval P190018/S027 · decided 2024-05-21
Approval details
- PMA number
- P190018
- Supplement
- S027
- Supplement type
- Normal 180 Day Track
- 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
- intraocular lens
- Applicant
- Alcon Laboratories, LLC
- Date received
- 2023-09-07
- Decision date
- 2024-05-21
- Days to decision
- 257 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- Approval for expanding the dioptric power range for Clareon Vivity Extended Vision IOLs in both the lens case and the AutonoMe Automated Pre-loaded Delivery System
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