- Device
- TECNIS Symfony OptiBlue Extended Range of Vision (ERV) IOL, TECNIS Symfony Toric II OptiBlue Extended Range of Vision (E
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- PMA number
- P980040
- Supplement
- S139
- Product code
- HQL
- Generic name
- intraocular lens
- Decision date
- 2021-11-15
- Decision code
- APPR
- Date received
- 2021-06-04
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for changes to lathe cutting and cryotumbling processes for manufacturing of TECNIS Symfony and TECNIS Symfony Toric II OptiBlue Extended Range of Vision Intraocular Lenses.