Clareon Toric Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon Toric Aspheric UV Absorbing Intraocular Lens
FDA premarket approval P190018/S038 · decided 2024-12-16
Approval details
- PMA number
- P190018
- Supplement
- S038
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Clareon Toric Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon Toric Aspheric UV Absorbing Intraocular Lens
- Generic name
- intraocular lens
- Applicant
- Alcon Laboratories, LLC
- Date received
- 2024-09-17
- Decision date
- 2024-12-16
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- approval for an increase in the dioptric power range to +6.0-34.0 D for the Clareon Toric Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon Toric Aspheric UV Absorbing Intraocular Lens (IOL), Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), and Clareon Aspheric UV Absorbing Intraocular Lens (IOL) models
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