- Device
- The SENSAR 1-Piece IOL with SmartLOAD Delivery Technology, The TECNIS 1-Piece IOL with SmartLOAD Delivery Technology, Th
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- PMA number
- P980040
- Supplement
- S144
- Product code
- HQL
- Generic name
- intraocular lens
- Decision date
- 2022-02-14
- Decision code
- APPR
- Date received
- 2021-12-20
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a manufacturing site located at AMO Groningen BV, Groningen, Groningen, 9728, NX, Netherlands as an alternative manufacturing and sterilization facility for the following with SmartLOAD Delivery Technology: SENSAR 1-Piece IOL, TECNIS 1-Piece IOL, TECNIS OptiBlue 1-Piece IOL and TECNIS Eyhance 1-Piece IOL.