- Device
- TECNIS Symfony™ OptiBlue® Extended Range of Vision (ERV) IOL with TECNIS Simplicity® Delivery System, Model DXR00V; TECN
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- PMA number
- P980040
- Supplement
- S142
- Product code
- HQL
- Generic name
- intraocular lens
- Decision date
- 2021-12-23
- Decision code
- APPR
- Date received
- 2021-10-01
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for packaging the TECNIS Symfony OptiBlue Extended Range of Vision (ERV) IOL and the TECNIS Symfony Toric II OptiBlue ERV IOLs with the TECNIS Simplicity Delivery System.