PMA P040020S113
- Device
- AcrySof ReSTOR Posterior Chamber Intraocular Lens (IOL)
- Applicant
- Alcon Research, Ltd.
- PMA number
- P040020
- Supplement
- S113
- Product code
- MFK
- Decision date
- 2025-02-14
- Classification
- Ophthalmic
- Generic name
- Lens, multifocal intraocular
- Approval order statement
- a change in the final cleaning process for AcrySof single-piece monofocal and multifocal lenses
Current openFDA PMA Record#
- Device
- AcrySof ReSTOR Posterior Chamber Intraocular Lens (IOL)
- Applicant
- Alcon Research, Ltd.
- PMA number
- P040020
- Supplement
- S113
- Product code
- MFK
- Generic name
- Lens, multifocal intraocular
- Decision date
- 2025-02-14
- Decision code
- OK30
- Date received
- 2025-01-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a change in the final cleaning process for AcrySof single-piece monofocal and multifocal lenses