Clareon Aspheric Hydrophobic Acrylic Intraocular Lens with the AutonoMe Pre-Loaded Delivery System, Clareon Toric Aspher
FDA premarket approval P190018/S019 · decided 2022-05-03
Approval details
- PMA number
- P190018
- Supplement
- S019
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Clareon Aspheric Hydrophobic Acrylic Intraocular Lens with the AutonoMe Pre-Loaded Delivery System, Clareon Toric Aspher
- Generic name
- intraocular lens
- Applicant
- Alcon Laboratories, LLC
- Date received
- 2022-04-06
- Decision date
- 2022-05-03
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- Transfer of the nozzle coating process during manufacturing of the AutonoMe Automated Pre-loaded Delivery System from Alcon Huntington, West Virginia to Alcon Laboratories, Ireland.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.