TECNIS Next-Generation Presbyopia-Correcting IOL
FDA premarket approval P980040/S156 · decided 2023-05-23
Approval details
- PMA number
- P980040
- Supplement
- S156
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- TECNIS Next-Generation Presbyopia-Correcting IOL
- Generic name
- Lens, multifocal intraocular
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2022-12-02
- Decision date
- 2023-05-23
- Days to decision
- 172 days
- Decision code
- APPR
- Product code
- MFK
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Approval for TECNIS Next-Generation Presbyopia-Correcting (PC) Intraocular lens (IOL) with TECNIS SimplicityTM Delivery System, Model DRN00V which is a design modification of TECNIS Synergy IOL, Model DFR00V.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| ELITA™ Femtosecond Laser System, ELITA™ Patient Interface (K223566) | Johnson & Johnson Surgical Vision, Inc. | 2023-04-14 |
| VERITAS Phacoemulsification Console, VERITAS Advanced Fluidics Pack and Advanced Infusion Pack, VERITAS Swivel Handpiece, VERITAS Advanced Foot Pedal, VERITAS Remote Control (K203060) | Johnson & Johnson Surgical Vision, Inc. | 2021-03-12 |
| UNFOLDER Vitan Inserter (K191949) | Johnson & Johnson Surgical Vision, Inc. | 2019-09-13 |
| COMPACT INTUITIV System, COMPACT INTUITIV Wireless Remote Control, COMPACT INTUITIV Four-Button Foot Pedal, COMPACT INTUITIV Closed-Toe Foot Pedal (K191933) | Johnson & Johnson Surgical Vision, Inc. | 2019-08-16 |