Tecnis Multifocal Toric II Intraocular Lenses (IOL)
FDA premarket approval P980040/S107 · decided 2020-02-28
Approval details
- PMA number
- P980040
- Supplement
- S107
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Tecnis Multifocal Toric II Intraocular Lenses (IOL)
- Generic name
- intraocular lens
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2019-09-03
- Decision date
- 2020-02-28
- Days to decision
- 178 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Approval of the TECNIS Multifocal Toric II IOLs, Models ZKU150, ZKU225, ZKU300, ZKU375 and ZLU150, ZLU225, ZLU300, ZLU375.
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