Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL) and Clareon PanOptix Hydrophobic Acrylic IOL
FDA premarket approval P190018/S016 · decided 2021-12-22
Approval details
- PMA number
- P190018
- Supplement
- S016
- 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
- 2021-11-30
- Decision date
- 2021-12-22
- Days to decision
- 22 days
- Decision code
- OK30
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- Reduction of the Clareon Intraocular Lenses (IOLs) plan view inspection from a 100% inspection to a statistical sampling plan in Alcon Ireland facility.
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