- Device
- TECNIS® Multifocal 3-Piece IOL, Model ZMA00
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- PMA number
- P080010
- Supplement
- S025
- Product code
- MFK
- Generic name
- Lens, multifocal intraocular
- Decision date
- 2024-06-17
- Decision code
- OK30
- Date received
- 2024-05-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- add a new haptic-loop inspection vision system to the production process of the SENSAR® Soft Acrylic Posterior Chamber IOL, Models AR40e, AR40E, and AR40M, TECNIS® Foldable Acrylic IOL with OptiEdge, ZA9003, and TECNIS® Multifocal 3-PC, Model ZMA00 IOLs at the JJSV Añasco, Puerto Rico manufacturing site