PMA P040020S082
- Device
- AcrySof IQ ReSTOR Posterior Chamber Intraocular Lens
- Applicant
- Alcon Research, Ltd.
- PMA number
- P040020
- Supplement
- S082
- Product code
- MFK
- Decision date
- 2018-10-04
- Classification
- Lens, Multifocal Intraocular
- Generic name
- Lens, multifocal intraocular
- Approval order statement
- Introduce an alternate manufacturing tool to be used during the AcrySof monomer formulation process.
Current openFDA PMA Record#
- Device
- AcrySof IQ ReSTOR Posterior Chamber Intraocular Lens
- Applicant
- Alcon Research, Ltd.
- PMA number
- P040020
- Supplement
- S082
- Product code
- MFK
- Generic name
- Lens, multifocal intraocular
- Decision date
- 2018-10-04
- Decision code
- OK30
- Date received
- 2018-09-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Introduce an alternate manufacturing tool to be used during the AcrySof monomer formulation process.