PMA P040020S104
- Device
- AcrySof® IQ ReSTOR® Posterior Chamber Intraocular Lenses
- Applicant
- Alcon Research, Ltd.
- PMA number
- P040020
- Supplement
- S104
- Product code
- MFK
- Decision date
- 2022-12-20
- Generic name
- Lens, multifocal intraocular
- Approval order statement
- Change from two fixtures to a single fixture used for lens cleaning, extraction, vacuum drying and plasma treatment processes.
Current openFDA PMA Record#
- Device
- AcrySof® IQ ReSTOR® Posterior Chamber Intraocular Lenses
- Applicant
- Alcon Research, Ltd.
- PMA number
- P040020
- Supplement
- S104
- Product code
- MFK
- Generic name
- Lens, multifocal intraocular
- Decision date
- 2022-12-20
- Decision code
- OK30
- Date received
- 2022-11-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change from two fixtures to a single fixture used for lens cleaning, extraction, vacuum drying and plasma treatment processes.