The SENSAR 1-Piece IOL with SmartLOAD Delivery Technology, The TECNIS 1-Piece IOL with SmartLOAD Delivery Technology, Th
FDA premarket approval P980040/S144 · decided 2022-02-14
Approval details
- PMA number
- P980040
- Supplement
- S144
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- The SENSAR 1-Piece IOL with SmartLOAD Delivery Technology, The TECNIS 1-Piece IOL with SmartLOAD Delivery Technology, Th
- Generic name
- intraocular lens
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2021-12-20
- Decision date
- 2022-02-14
- Days to decision
- 56 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Approval for a manufacturing site located at AMO Groningen BV, Groningen, Groningen, 9728, NX, Netherlands as an alternative manufacturing and sterilization facility for the following with SmartLOAD Delivery Technology: SENSAR 1-Piece IOL, TECNIS 1-Piece IOL, TECNIS OptiBlue 1-Piece IOL and TECNIS Eyhance 1-Piece IOL.
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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 |