- Device
- TECNIS Synergy IOL with TECNIS Simplicity Delivery System, TECNIS Synergy Toric II IOL with TECNIS Simplicity Delivery S
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- PMA number
- P980040
- Supplement
- S138
- Product code
- HQL
- Generic name
- intraocular lens
- Decision date
- 2021-06-29
- Decision code
- OK30
- Date received
- 2021-06-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modification to the endotoxin extraction method currently conducted at AMO Groningen B.V. manufacturing facility for the subject devices.