Clareon PanOptix Trifocal UV Absorbing Hydrophobic Intraocular Lens (IOL), Clareon PanOptix Toric Trifocal Hydrophobic I
FDA premarket approval P190018/S012 · decided 2022-02-14
Approval details
- PMA number
- P190018
- Supplement
- S012
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Clareon PanOptix Trifocal UV Absorbing Hydrophobic Intraocular Lens (IOL), Clareon PanOptix Toric Trifocal Hydrophobic I
- Generic name
- intraocular lens
- Applicant
- Alcon Laboratories, LLC
- Date received
- 2021-08-26
- Decision date
- 2022-02-14
- Days to decision
- 172 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- Approval for additional manufacturing sites at Alcon Research, LLC (AODC-South) located at 6065 Kyle Lane Huntington, West Virginia and Alcon Research, LLC (AODC-North) located at 2 Vision Lane Lesage, West Virginia. The AODC-South facility performs the Injection Moulding through the Cosmetic Inspection manufacturing steps and the AODC-North facility performs the Pouching & Barseal through the Overwrap steps of the manufacturing process, as well as sterilization and distribution.
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