PMA P990080
- Device
- TECNIS™ 3-Piece Acrylic Monofocal, Model ZA9003
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- PMA number
- P990080
- Supplement
- S056
- Product code
- HQL
- Decision date
- 2026-06-03
- Generic name
- intraocular lens
- Approval order statement
- an alternative supplier for the edge blockers for the 3-piece IOLs (AR40e, AR40E, AR40M, AR40MN, ZMA00, and ZA9003)
Current openFDA PMA Record#
- Device
- TECNIS™ 3-Piece Acrylic Monofocal, Model ZA9003
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- PMA number
- P990080
- Supplement
- S066
- Product code
- HQL
- Generic name
- intraocular lens
- Decision date
- 2026-06-03
- Decision code
- OK30
- Date received
- 2026-05-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- an alternative supplier for the edge blockers for the 3-piece IOLs (AR40e, AR40E, AR40M, AR40MN, ZMA00, and ZA9003)