TECNIS Synergy IOL with TECNIS Simplicity® Delivery System, TECNIS Synergy Toric II IOL with TECNIS Simplicity® Delive
FDA premarket approval P980040/S135 · decided 2021-06-07
Approval details
- PMA number
- P980040
- Supplement
- S135
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TECNIS Synergy IOL with TECNIS Simplicity® Delivery System, TECNIS Synergy Toric II IOL with TECNIS Simplicity® Delive
- Generic name
- intraocular lens
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2021-05-10
- Decision date
- 2021-06-07
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Complete the manufacturing for the TECNIS Synergy lOL with TECNIS Simplicity® Delivery System, Model DFR00V and TECNIS Synergy Toric II lOL with TECNIS Simplicity® Delivery System, Models DFW150, DFW225, DFW300, DFW375 at the AMO Puerto Rico Manufacturing Inc. facility.
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510(k) clearances by this applicant
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|---|---|---|
| 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 |