Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon ToricAspheric Hydrophobic Acrylic Intraocular Lens,
FDA premarket approval P190018/S043 · decided 2025-08-25
Approval details
- PMA number
- P190018
- Supplement
- S043
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon ToricAspheric Hydrophobic Acrylic Intraocular Lens,
- Generic name
- intraocular lens
- Applicant
- Alcon Laboratories, LLC
- Date received
- 2025-07-28
- Decision date
- 2025-08-25
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- the expansion of a clean room for manufacturing for the toric and non-toric Acrysof and Clareon IOLs
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