Clareon Aspheric Hydrophobic Acrylic Intraocular Lenses
FDA premarket approval P190018/S039 · decided 2025-06-18
Approval details
- PMA number
- P190018
- Supplement
- S039
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Clareon Aspheric Hydrophobic Acrylic Intraocular Lenses
- Generic name
- intraocular lens
- Applicant
- Alcon Laboratories, LLC
- Date received
- 2024-12-10
- Decision date
- 2025-06-18
- Days to decision
- 190 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- approval for a manufacturing site located at [Alcon Huntington West Virginia, 2 Vision Lane, Lesage, West Virginia 25537 for manufacturing processes starting with injection molding and progressing through primary packaging and seal integrity testing.
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