- Device
- AcrySof IQ PanOptix Trifocal Intraocular Lens and AcrySof IQ PanOptix Toric Trifocal Intraocular Lens
- Applicant
- Alcon Research, Ltd.
- PMA number
- P040020
- Supplement
- S087
- Product code
- MFK
- Generic name
- Lens, multifocal intraocular
- Decision date
- 2019-08-26
- Decision code
- APPR
- Date received
- 2019-01-31
- Supplement type
- Panel Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order 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.