PMA P040020S116
- Device
- AcrySof® IQ ReSTOR® Posterior Chamber Intraocular Lenses
- Applicant
- Alcon Research, Ltd.
- PMA number
- P040020
- Supplement
- S116
- Product code
- MFK
- Decision date
- 2025-09-18
- Classification
- Ophthalmic
- Generic name
- Lens, multifocal intraocular
- Approval order statement
- automation of the wafer welding and assembly process for Clareon IOLs
Current openFDA PMA Record#
- Device
- AcrySof® IQ ReSTOR® Posterior Chamber Intraocular Lenses
- Applicant
- Alcon Research, Ltd.
- PMA number
- P040020
- Supplement
- S116
- Product code
- MFK
- Generic name
- Lens, multifocal intraocular
- Decision date
- 2025-09-18
- Decision code
- OK30
- Date received
- 2025-08-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- automation of the wafer welding and assembly process for Clareon IOLs