- Device
- TECNIS® 3-Piece Multifocal
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- PMA number
- P080010
- Supplement
- S022
- Product code
- MFK
- Generic name
- Lens, multifocal intraocular
- Decision date
- 2024-09-27
- Decision code
- APPR
- Date received
- 2023-06-28
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- software improvements made to optical metrology system used for 100 percent in-line inspection of TECNIS 3-Piece Acrylic Monofocal, TECNIS 1-Piece with TECNIS® iTec Preloaded Delivery System, SENSAR® 3-Piece Monofocal, TECNIS® CL Foldable Silicone, and 5ODEL SI-11NB UV Absorbing Silicone Posterior intraocular lenses