- Device
- AcrySof IQ ReSTOR Posterior Chamber Intraocular Lenses
- Applicant
- Alcon Research, Ltd.
- PMA number
- P040020
- Supplement
- S091
- Product code
- MFK
- Generic name
- Lens, multifocal intraocular
- Decision date
- 2019-08-01
- Decision code
- OK30
- Date received
- 2019-07-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of a 100% Ethylene Oxide (EO) sterilization chamber, integrated aeration cell, and supporting equipment at the Alcon Huntington manufacturing facility.