Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon Toric Aspheric Hydrophobic Acrylic Intraocular Lens
FDA premarket approval P190018 · decided 2020-01-07
Approval details
- PMA number
- P190018
- Trade name
- Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon Toric Aspheric Hydrophobic Acrylic Intraocular Lens
- Generic name
- intraocular lens
- Applicant
- Alcon Laboratories, LLC
- Date received
- 2019-07-11
- Decision date
- 2020-01-07
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- Approval for the Clareon and Clareon Toric Aspheric Hydrophobic Acrylic Intraocular Lens (IOL).Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL):The Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL) is indicated for primary implantation in the capsular bag in the posterior chamber of the eye for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed. Clareon Toric Aspheric Hydrophobic Acrylic Intraocular Lens (IOL):The Clareon Toric Asp
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.