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Device | TECNIS Symfony OptiBlue IOL, TECNIS Symfomy Toric II OptiBlue IOLs |
Generic Name | Extended depth of focus intraocular lens |
Applicant | Johnson & Johnson Surgical Vision, Inc. 31 Technology Drive Suite 200 Irvine, CA 92618 |
PMA Number | P980040 |
Supplement Number | S112 |
Date Received | 02/28/2020 |
Decision Date | 05/28/2020 |
Product Codes |
MJP POE |
Advisory Committee |
Ophthalmic |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for an addition to the TECNIS Symfony family of Extended Range of Vision one-piece IOLs manufactured from OptiBlue lens material. |