Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon PanOptix Hydrophobic Acrylic IOL
FDA premarket approval P190018/S032 · decided 2024-07-12
Approval details
- PMA number
- P190018
- Supplement
- S032
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon PanOptix Hydrophobic Acrylic IOL
- Generic name
- intraocular lens
- Applicant
- Alcon Laboratories, LLC
- Date received
- 2024-01-31
- Decision date
- 2024-07-12
- Days to decision
- 163 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- reduction from 100% to sampling plan for dimensional inspection of all Clareon and AcrySof Single-Piece toric lenses
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