TECNIS Symfony Toric II OptiBlue Extended Range of Vision IOL with TECNIS Simplicity Delivery System, Models DXW150-375;
FDA premarket approval P980040/S178 · decided 2025-10-24
Approval details
- PMA number
- P980040
- Supplement
- S178
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TECNIS Symfony Toric II OptiBlue Extended Range of Vision IOL with TECNIS Simplicity Delivery System, Models DXW150-375;
- Generic name
- intraocular lens
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2025-09-26
- Decision date
- 2025-10-24
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- the implementation of a revised sampling process for torque testing of the pre-loaded Simplicity and SmartLoad delivery systems at the JJSV-AMO manufacturing facility in Groningen, The Netherlands
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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 |
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| 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 |