TECNIS Symfony Toric Extended Range of Vision IOL and TECNIS Toric 1-Piece IOL
FDA premarket approval P980040/S091 · decided 2018-06-11
Approval details
- PMA number
- P980040
- Supplement
- S091
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TECNIS Symfony Toric Extended Range of Vision IOL and TECNIS Toric 1-Piece IOL
- Generic name
- intraocular lens
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2018-05-15
- Decision date
- 2018-06-11
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Manufacture the TECNIS® Toric 1-Piece IOL, Models ZCT150, ZCT225, ZCT300, ZCT375, ZCT400, ZCT450, ZCT525 and ZCT600, and the TECNIS® Symfony Toric Extended Range of Vision IOLs, Models ZXT150, ZXT225, ZXT300 and ZXT375, at Johnson & Johnson Surgical Vision, Inc.s (J&J Vision) AMO Puerto Rico Manufacturing, Inc. facility in Añasco, Puerto Rico.
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