Lens, Multifocal Intraocular
Basic Information
- Device Name
- Lens, Multifocal Intraocular
- Trade Name
- AcrySof IQ PanOptix Trifocal Intraocular Lens and AcrySof IQ PanOptix Toric Trifocal Intraocular Lens
- PMA Number
- P040020
- Supplement Number
- S087
- Device Class
- FDA Class 3
- Product Code
- MFK
- Generic Name
- Lens, multifocal intraocular
- Regulation Number
- 886.3600
- Medical Specialty
- Ophthalmic
- Advisory Committee
- Ophthalmic
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- August 26, 2019
- Date Received
- January 31, 2019
- Supplement Type
- Panel Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
- Docket Number
- 19M-4153
Advisory Committee Statement
Approval for the AcrySof® IQ PanOptix® Trifocal Intraocular lens, which is indicated for primary implantation in the capsular bag in the posterior chamber of the eye 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 improved intermediate and near visual acuity, while maintaining comparable distance visual acuity with a reduced need for eyeglasses, compared to a monofocal IOL.Approval for the AcrySof® IQ PanOptix® Toric Trifocal Intraocular lens, which is indicated for primary implantation in the capsular bag in the posterior chamber of the eye for the visual correction of aphakia and the reduction of residual refractive astigmatism, in adult patients in whom a cataractous lens has been removed. The lens mitigates the effects of presbyopia by providing improved intermediate and near visual acuity, while maintaining comparable distance visual acuity with a reduced need for eyeglasses, compared to a monofocal IOL.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MFK | Lens, Multifocal Intraocular | FDA class 3 | Ophthalmic |