TECNIS Synergy Intraocular Lens, TECNIS Synergy Toric II Intraocular Lens, TECNIS Synergy IOL with TECNIS Simplicity Del
FDA premarket approval P980040/S124 · decided 2021-04-28
Approval details
- PMA number
- P980040
- Supplement
- S124
- Supplement type
- Panel Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- TECNIS Synergy Intraocular Lens, TECNIS Synergy Toric II Intraocular Lens, TECNIS Synergy IOL with TECNIS Simplicity Del
- Generic name
- Lens, multifocal intraocular
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2020-10-02
- Decision date
- 2021-04-28
- Days to decision
- 208 days
- Decision code
- APPR
- Product code
- MFK
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Approval for TECNIS Synergy Intraocular Lens (Model ZFR00V), TECNIS Synergy Toric II Intraocular Lens (Models ZFW150, ZFW225, ZFW300, and ZFW375), TECNIS Synergy IOL with TECNIS Simplicity Delivery System (Model DFR00V), TECNIS Synergy Toric II IOL with TECNIS Simplicity Delivery System (Models DFW150, DFW225, DFW300 and DFW375).The TECNIS Synergy IOL, Model ZFR00V, is indicated for primary implantation for the visual correction of aphakia in adult patients, with less than 1 diopter of pre-exist
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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 |