- Device
- TECNIS 1-Piece IOL with TECNIS® iTEC Preloaded Delivery System Model PCB00, TECNIS Multifocal 1-PC IOL with TECNIS® iTEC
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- PMA number
- P980040
- Supplement
- S154
- Product code
- HQL
- Generic name
- intraocular lens
- Decision date
- 2022-12-15
- Decision code
- OK30
- Date received
- 2022-11-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Changes to the torque testing of the preloaded IOL delivery systems of soft acrylic one-piece IOLs manufactured in Puerto Rico.