PMA P040020S117
- Device
- AcrySof IQ ReSTOR Posterior Chamber Intraocular Lenses
- Applicant
- Alcon Research, Ltd.
- PMA number
- P040020
- Supplement
- S117
- Product code
- MFK
- Decision date
- 2025-12-12
- Classification
- Ophthalmic
- Generic name
- Lens, multifocal intraocular
- Approval order statement
- approval of a new cleanroom (Controlled Environment (CE)) for Intraocular lenses manufactured at Alcon Huntington, West Virginia
Current openFDA PMA Record#
- Device
- AcrySof IQ ReSTOR Posterior Chamber Intraocular Lenses
- Applicant
- Alcon Research, Ltd.
- PMA number
- P040020
- Supplement
- S117
- Product code
- MFK
- Generic name
- Lens, multifocal intraocular
- Decision date
- 2025-12-12
- Decision code
- OK30
- Date received
- 2025-11-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval of a new cleanroom (Controlled Environment (CE)) for Intraocular lenses manufactured at Alcon Huntington, West Virginia