- Device
- AcrySof® ReSTOR Apodized Diffractive Optic Posterior Chamber IOL
- Applicant
- Alcon Research, Ltd.
- PMA number
- P040020
- Supplement
- S108
- Product code
- MFK
- Generic name
- Lens, multifocal intraocular
- Decision date
- 2024-07-12
- Decision code
- APPR
- Date received
- 2024-01-31
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- reduction from 100% to sampling plan for dimensional inspection of all Clareon and AcrySof Single-Piece toric lenses