PMA P190018S011
- Device
- Clareon Intraocular Lenses with the AutonoMe Delivery System
- Applicant
- Alcon Laboratories, LLC
- PMA number
- P190018
- Supplement
- S011
- Product code
- HQL
- Decision date
- 2021-04-22
- Generic name
- intraocular lens
- Approval order statement
- Add an alternate supplier for a raw material (i.e. initiator) used in the manufacturing process.
Current openFDA PMA Record#
- Device
- Clareon Intraocular Lenses with the AutonoMe Delivery System
- Applicant
- Alcon Laboratories, LLC
- PMA number
- P190018
- Supplement
- S011
- Product code
- HQL
- Generic name
- intraocular lens
- Decision date
- 2021-04-22
- Decision code
- OK30
- Date received
- 2021-03-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add an alternate supplier for a raw material (i.e. initiator) used in the manufacturing process.