PMA P190018S049
- Device
- Clareon® Aspheric Hydrophobic Acrylic Intraocular Lens (IOL) and Clareon® PanOptix Hydrophobic Acrylic IOL
- Applicant
- Alcon Laboratories, LLC
- PMA number
- P190018
- Supplement
- S049
- Product code
- HQL
- Decision date
- 2026-03-02
- Classification
- Ophthalmic
- Generic name
- intraocular lens
- Approval order statement
- addition of a new purified water system at the Alcon Huntington North Manufacturing Site
Current openFDA PMA Record#
- Device
- Clareon® Aspheric Hydrophobic Acrylic Intraocular Lens (IOL) and Clareon® PanOptix Hydrophobic Acrylic IOL
- Applicant
- Alcon Laboratories, LLC
- PMA number
- P190018
- Supplement
- S049
- Product code
- HQL
- Generic name
- intraocular lens
- Decision date
- 2026-03-02
- Decision code
- OK30
- Date received
- 2026-02-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- addition of a new purified water system at the Alcon Huntington North Manufacturing Site