- Device
- SENSAR® 1-Piece IOL, Model AAB00, TECNIS® Monofocal 1-Piece IOL, Model ZCB00, TECNIS® Multifocal 1-Piece IOL, Model ZMB0
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- PMA number
- P980040
- Supplement
- S152
- Product code
- HQL
- Generic name
- intraocular lens
- Decision date
- 2022-11-17
- Decision code
- OK30
- Date received
- 2022-10-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Expansion of the manufacturing facility in building 3 of the Puerto Rico facility.