- Device
- TECNIS Foldable Acrylic IOL with OptiEdge, 13.0 mm, ZA9003
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- PMA number
- P990080
- Supplement
- S065
- Product code
- HQL
- Generic name
- intraocular lens
- Decision date
- 2026-01-12
- Decision code
- OK30
- Date received
- 2025-12-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- the qualification of additional sterilization chambers, preconditioning and aeration rooms, and 2x (double) terminal sterilization approaches