PMA P040020S077
- Device
- AcrySof ReSTOR Intraocular Lenses
- Applicant
- Alcon Research, Ltd.
- PMA number
- P040020
- Supplement
- S077
- Product code
- MFK
- Decision date
- 2018-01-08
- Classification
- Lens, Multifocal Intraocular
- Generic name
- Lens, multifocal intraocular
- Approval order statement
- Elimination of a test performed during set-up of the manufacturing of your Acrysof and AcrySof ReSTOR multi-piece intraocular lenses.
Current openFDA PMA Record#
- Device
- AcrySof ReSTOR Intraocular Lenses
- Applicant
- Alcon Research, Ltd.
- PMA number
- P040020
- Supplement
- S077
- Product code
- MFK
- Generic name
- Lens, multifocal intraocular
- Decision date
- 2018-01-08
- Decision code
- OK30
- Date received
- 2017-12-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Elimination of a test performed during set-up of the manufacturing of your Acrysof and AcrySof ReSTOR multi-piece intraocular lenses.