PMA P040020S099
- Device
- AcrySof IQ ReSTOR Posterior Chamber Intraocular Lens
- Applicant
- Alcon Research, Ltd.
- PMA number
- P040020
- Supplement
- S099
- Product code
- MFK
- Decision date
- 2021-07-14
- Generic name
- Lens, multifocal intraocular
- Approval order statement
- Remove constant T microvacuole testing as release criteria for Alcon AcrySof® and AcrySof® IQ ReSTOR® intraocular lenses.
Current openFDA PMA Record#
- Device
- AcrySof IQ ReSTOR Posterior Chamber Intraocular Lens
- Applicant
- Alcon Research, Ltd.
- PMA number
- P040020
- Supplement
- S099
- Product code
- MFK
- Generic name
- Lens, multifocal intraocular
- Decision date
- 2021-07-14
- Decision code
- OK30
- Date received
- 2021-06-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Remove constant T microvacuole testing as release criteria for Alcon AcrySof® and AcrySof® IQ ReSTOR® intraocular lenses.