Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL) and Clareon PanOptix Hydrophobic Acrylic IOL works
FDA premarket approval P190018/S035 · decided 2024-05-31
Approval details
- PMA number
- P190018
- Supplement
- S035
- 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 works
- Generic name
- intraocular lens
- Applicant
- Alcon Laboratories, LLC
- Date received
- 2024-05-03
- Decision date
- 2024-05-31
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- implementation of an automated casting and wafer handling system for the Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL) and Clareon PanOptix Hydrophobic Acrylic IOLs at Alcon Huntington, West Virginia manufacturing site
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