- Device
- TECNIS Synergy™ IOL with TECNIS Simplicity® Delivery System, TECNIS Synergy™ Toric II IOL with TECNIS Simplicity® Delive
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- PMA number
- P980040
- Supplement
- S135
- Product code
- HQL
- Generic name
- intraocular lens
- Decision date
- 2021-06-07
- Decision code
- OK30
- Date received
- 2021-05-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Complete the manufacturing for the TECNIS Synergy lOL with TECNIS Simplicity® Delivery System, Model DFR00V and TECNIS Synergy Toric II lOL with TECNIS Simplicity® Delivery System, Models DFW150, DFW225, DFW300, DFW375 at the AMO Puerto Rico Manufacturing Inc. facility.