TECNIS Eyhance IOL with TECNIS Simplicity Delivery System, Model DIB00, TECNIS Eyhance Toric II IOLs with TECNIS Simp
FDA premarket approval P980040/S155 · decided 2022-12-12
Approval details
- PMA number
- P980040
- Supplement
- S155
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TECNIS Eyhance IOL with TECNIS Simplicity Delivery System, Model DIB00, TECNIS Eyhance Toric II IOLs with TECNIS Simp
- Generic name
- intraocular lens
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2022-11-18
- Decision date
- 2022-12-12
- Days to decision
- 24 days
- Decision code
- OK30
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Adding an alternate manufacturing and sterilization site at AMO Groningen B.V., Van Swietenlaan 5, Groningen, The Netherlands 9728NX for TECNISEyhance IOL with TECNIS Simplicity Delivery System, Model DIB00, and TECNIS Eyhance Toric II IOLs with TECNIS Simplicity Delivery System, Models DIU150-600.
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510(k) clearances by this applicant
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|---|---|---|
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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 |