PMA P990080S064
- Device
- TECNIS 3-Piece Acrylic Monofocal, Model ZA9003
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- PMA number
- P990080
- Supplement
- S064
- Product code
- HQL
- Decision date
- 2025-09-02
- Classification
- Ophthalmic
- Generic name
- intraocular lens
- Approval order statement
- a modification of the sampling size for two in-process identification tests
Current openFDA PMA Record#
- Device
- TECNIS 3-Piece Acrylic Monofocal, Model ZA9003
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- PMA number
- P990080
- Supplement
- S064
- Product code
- HQL
- Generic name
- intraocular lens
- Decision date
- 2025-09-02
- Decision code
- OK30
- Date received
- 2025-08-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a modification of the sampling size for two in-process identification tests