- Device
- TECNIS Foldable Acrylic IOL with OptiEdge
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- PMA number
- P990080
- Supplement
- S062
- Product code
- HQL
- Generic name
- intraocular lens
- Decision date
- 2025-09-10
- Decision code
- APPR
- Date received
- 2024-12-23
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval for a new sterilization manufacturing site located at COSMED Group of Dominican Republic, Zona Franca Las Americas Km. 22 Autopista Las Americas, Santo Domingo Este Calle 15Esq. Calle 10, Santo Domingo, Santo Domingo, Dominican Republic