TECNIS Eyhance IOL, TECNIS Eyhance IOL with SmartLOAD Delivery Technology, TECNIS Eyhance IOL with TECNIS Simplicity Del
FDA premarket approval P980040/S117 · decided 2020-12-29
Approval details
- PMA number
- P980040
- Supplement
- S117
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- TECNIS Eyhance IOL, TECNIS Eyhance IOL with SmartLOAD Delivery Technology, TECNIS Eyhance IOL with TECNIS Simplicity Del
- Generic name
- intraocular lens
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2020-06-15
- Decision date
- 2020-12-29
- Days to decision
- 197 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- TECNIS EyhanceTM IOL, Model ICB00; TECNIS EyhanceTM IOL with SmartLOADTM Delivery Technology, Model GIB00; TECNIS EyhanceTM IOL with TECNIS SimplicityTM Delivery System, Model DIB00; TECNIS EyhanceTM Toric II IOLs, Models ICU150-600; and TECNIS EyhanceTM Toric II IOLs with TECNIS SimplicityTM Delivery System, Models DIU150-600, which are an extension of the TECNIS family of one-piece IOLs that incorporate an optical modification.
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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 |