- Device
- TECNIS 1-Piece IOL with TECNIS Simplicity Delivery System, TECNIS OptiBlue 1-Piece IOL with TECNIS Simplicity Delivery S
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- PMA number
- P980040
- Supplement
- S118
- Product code
- HQL
- Generic name
- intraocular lens
- Decision date
- 2020-11-04
- Decision code
- APPR
- Date received
- 2020-06-22
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for the alternate manufacturing and sterilization site is located at AMO Groningen B.V., 5 Van Swietenlaan, Groningen, The Netherlands 9728NX.