- Device
- The SENSAR/TECNIS 1-Piece IOL with SmartLOAD Delivery Technology and The TECNIS OptiBlue 1-Piece IOL with SmartLOAD Deli
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- PMA number
- P980040
- Supplement
- S095
- Product code
- HQL
- Generic name
- intraocular lens
- Decision date
- 2019-09-13
- Decision code
- APPR
- Date received
- 2018-12-03
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for an additional packaging configuration for SENSAR®, TECNIS® and TECNIS® OptiBlue one-piece IOLs into the new SmartLOAD Delivery Technology