Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL) and Clareon PanOptix Hydrophobic Acrylic IOL
FDA premarket approval P190018/S045 · decided 2025-12-12
Approval details
- PMA number
- P190018
- Supplement
- S045
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL) and Clareon PanOptix Hydrophobic Acrylic IOL
- Generic name
- intraocular lens
- Applicant
- Alcon Laboratories, LLC
- Date received
- 2025-11-04
- Decision date
- 2025-12-12
- Days to decision
- 38 days
- Decision code
- OK30
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- approval of a new cleanroom (Controlled Environment (CE)) for Intraocular lenses manufactured at Alcon Huntington, West Virginia
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