- Device
- TECNIS® Symfony™, TECNIS® Symfony™ Toric, TECNIS® Symfony™ OptiBlue®, TECNIS® Symfony™ OptiBlue® with TECNIS Simplicity®
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- PMA number
- P980040
- Supplement
- S149
- Product code
- HQL
- Generic name
- intraocular lens
- Decision date
- 2022-07-25
- Decision code
- OK30
- Date received
- 2022-07-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Reduction in frequency of flat-time testing for 1-piece acrylic intraocular lenses.