- Device
- TECNIS Symfony Toric II OptiBlue Extended Range of Vision (ERV) IOLs
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- PMA number
- P980040
- Supplement
- S131
- Product code
- HQL
- Generic name
- intraocular lens
- Decision date
- 2021-03-08
- Decision code
- OK30
- Date received
- 2021-02-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Additional image quality manufacturing process step for the TECNIS Symfony Toric II OptiBlue ERV lOLs, Models ZXW50, ZXW225, ZXW300, ZXW375 manufactured at the AMO Groningen B.V. facility.