TECNIS SYMFONY EXTENDED RANGE OF VISION INTRAOCULAR LENS
FDA premarket approval P980040/S065 · decided 2016-07-15
Approval details
- PMA number
- P980040
- Supplement
- S065
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- TECNIS SYMFONY EXTENDED RANGE OF VISION INTRAOCULAR LENS
- Generic name
- Extended depth of focus intraocular lens
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2016-01-19
- Decision date
- 2016-07-15
- Days to decision
- 178 days
- Decision code
- APPR
- Product code
- POE
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Approval for the Tecnis Symfony Extended Range of Vision Intraocular Lens. The TECNIS® Symfony Extended Range of Vision IOL, Model ZXR00, is indicated for primary implantation for the visual correction of aphakia, in adult patients with less than 1 diopter of pre-existing corneal astigmatism, in whom a cataractous lens has been removed. The lens mitigates the effects of presbyopia by providing an extended depth of focus. Compared to an aspheric monofocal IOL, the lens provides improved intermedi
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