FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Intraocular Lens
PMA: P990080
·
Supplement: S065
·
Decision Jan 12, 2026
Classifications
1
FEI Numbers
0
Registration Numbers
0
Basic Information
- Device Name
- Intraocular Lens
- Trade Name
- TECNIS Foldable Acrylic IOL with OptiEdge, 13.0 mm, ZA9003
- PMA Number
- P990080
- Supplement Number
- S065
- Device Class
- FDA Class 3
- Product Code
- HQL
- Generic Name
- intraocular lens
- Regulation Number
- 886.3600
- Medical Specialty
- Ophthalmic
- Advisory Committee
- Ophthalmic
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- January 12, 2026
- Date Received
- December 15, 2025
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
the qualification of additional sterilization chambers, preconditioning and aeration rooms, and 2x (double) terminal sterilization approaches
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HQL | Intraocular Lens | FDA class 3 | Ophthalmic |