Clareon Intraocular Lenses with the AutonoMe Delivery System
FDA premarket approval P190018/S026 · decided 2023-08-10
Approval details
- PMA number
- P190018
- Supplement
- S026
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Clareon Intraocular Lenses with the AutonoMe Delivery System
- Generic name
- intraocular lens
- Applicant
- Alcon Laboratories, LLC
- Date received
- 2023-07-12
- Decision date
- 2023-08-10
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- Addition of an alternative manufacturer of Clareon intraocular lens (IOL) lens cases; and 2) using an alternative polypropylene raw material.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.