PMA P040020S112
- Device
- AcrySof IQ ReSTOR Posterior Chamber Intraocular Lenses
- Applicant
- Alcon Research, Ltd.
- PMA number
- P040020
- Supplement
- S112
- Product code
- MFK
- Decision date
- 2025-02-04
- Classification
- Ophthalmic
- Generic name
- Lens, multifocal intraocular
- Approval order statement
- adding an alternative supplier of 2-phenylethylacrylate (PEA) and 2-phenylethylmethacrylate (PEMA) for IOL manufacturing
Current openFDA PMA Record#
- Device
- AcrySof IQ ReSTOR Posterior Chamber Intraocular Lenses
- Applicant
- Alcon Research, Ltd.
- PMA number
- P040020
- Supplement
- S112
- Product code
- MFK
- Generic name
- Lens, multifocal intraocular
- Decision date
- 2025-02-04
- Decision code
- OK30
- Date received
- 2025-01-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- adding an alternative supplier of 2-phenylethylacrylate (PEA) and 2-phenylethylmethacrylate (PEMA) for IOL manufacturing