PMA P930014S126
- Device
- AcrySof™ IQ Vivity™ Extended Vision, Toric Extended Vision, Extended Vision UV Absorbing, and Toric Extended Vision UV A
- Applicant
- Alcon Laboratories, Inc.
- Product code
- POE
- Decision date
- 2020-02-26
- Generic name
- Extended depth of focus intraocular lens
- Approval order statement
- The AcrySof IQ Vivity Extended Vision IOL Model DFT015 is indicated for primary implantation for the visual correction of aphakia in adult patients with < 1.00 D of preoperative corneal astigmatism, in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens mitigates the effects of presbyopia by providing an extended depth of focus. Compared to an aspheric monofocal IOL, the lens provides improved intermediate and near visual acuity, while maintaining comparable distance visual acuity. The AcrySof IQ Vivity IOL is intended for capsular bag placement only.The AcrySof IQ Vivity Toric Extended Vision IOL Models DFT315, DFT415, and DFT515 are indicated for primary implantation for the visual correction of aphakia and for reduction of residual refractive astigmatism in adult patients with pre-existing corneal astigmatism, in whom a cataractous lens has been removed by extracapsular cataract extraction. The lenses mitigate the effects of presbyopia by providing an extended depth of focus. Compared to an aspheric monofocal IOL, the lenses provide improved intermediate and near visual acuity, while maintaining comparable distance visual acuity. The AcrySof IQ Vivity Toric IOLs are intended for capsular bag placement only.The AcrySof IQ Vivity Extended Vision UV Absorbing IOL Model DAT015 is indicated for primary implantation for the visual correction of aphakia in adult patients with < 1.00 D of preoperative corneal astigmatism, in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens mitigates the effects of presbyopia by providing an extended depth of focus. Compared to an aspheric monofocal IOL, the lens provides improved intermediate and near visual acuity, while maintaining comparable distance visual acuity. The AcrySof IQ Vivity UV Absorbing IOL is intended for capsular bag placement only.The AcrySof IQ Vivity Toric Extended Vision UV Absorbing IOL Models DAT315, DAT415, and DAT515 are indicated for primary implantation for the visual correction of aphakia and for reduction of residual refractive astigmatism in adult patients with pre-existing corneal astigmatism, in whom a cataractous lens has been removed by extracapsular cataract extraction. The lenses mitigate the effects of presbyopia by providing an extended depth of focus. Compared to an aspheric monofocal IOL, the lens provides improved intermediate and near visual acuity, while maintaining comparable distance visual acuity. The AcrySof IQ Vivity Toric UV Absorbing IOLs are intended for capsular bag placement only.
Current openFDA PMA Record#
- Device
- AcrySof™ IQ Vivity™ Extended Vision, Toric Extended Vision, Extended Vision UV Absorbing, and Toric Extended Vision UV A
- Applicant
- Alcon Laboratories, Inc.
- PMA number
- P930014
- Supplement
- S126
- Product code
- POE
- Generic name
- Extended depth of focus intraocular lens
- Decision date
- 2020-02-26
- Decision code
- APPR
- Date received
- 2019-08-09
- Supplement type
- Panel Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- The AcrySof IQ Vivity Extended Vision IOL Model DFT015 is indicated for primary implantation for the visual correction of aphakia in adult patients with < 1.00 D of preoperative corneal astigmatism, in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens mitigates the effects of presbyopia by providing an extended depth of focus. Compared to an aspheric monofocal IOL, the lens provides improved intermediate and near visual acuity, while maintaining comparable distance visual acuity. The AcrySof IQ Vivity IOL is intended for capsular bag placement only.The AcrySof IQ Vivity Toric Extended Vision IOL Models DFT315, DFT415, and DFT515 are indicated for primary implantation for the visual correction of aphakia and for reduction of residual refractive astigmatism in adult patients with pre-existing corneal astigmatism, in whom a cataractous lens has been removed by extracapsular cataract extraction. The lenses mitigate the effects of presbyopia by providing an extended depth of focus. Compared to an aspheric monofocal IOL, the lenses provide improved intermediate and near visual acuity, while maintaining comparable distance visual acuity. The AcrySof IQ Vivity Toric IOLs are intended for capsular bag placement only.The AcrySof IQ Vivity Extended Vision UV Absorbing IOL Model DAT015 is indicated for primary implantation for the visual correction of aphakia in adult patients with < 1.00 D of preoperative corneal astigmatism, in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens mitigates the effects of presbyopia by providing an extended depth of focus. Compared to an aspheric monofocal IOL, the lens provides improved intermediate and near visual acuity, while maintaining comparable distance visual acuity. The AcrySof IQ Vivity UV Absorbing IOL is intended for capsular bag placement only.The AcrySof IQ Vivity Toric Extended Vision UV Absorbing IOL Models DAT315, DAT415, and DAT515 are indicated for primary implantation for the visual correction of aphakia and for reduction of residual refractive astigmatism in adult patients with pre-existing corneal astigmatism, in whom a cataractous lens has been removed by extracapsular cataract extraction. The lenses mitigate the effects of presbyopia by providing an extended depth of focus. Compared to an aspheric monofocal IOL, the lens provides improv...