Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• Device: AcrySof™ IQ Vivity™ Extended Vision, Toric Extended Vision, Extended Vision UV Absorbing, and Toric Extended Vision UV A
• Generic Name: Extended depth of focus intraocular lens
• Regulation Number: 886.3600
• Applicant: Alcon Laboratories, Inc.; 6201 S. Fwy. Dr.; Fort Worth, TX 76134
• PMA Number: P930014
• Supplement Number: S126
• Date Received: 08/09/2019
• Decision Date: 02/26/2020
• Product Code: POE
• Docket Number: 20M-0986
• Notice Date: 02/28/2020
• Advisory Committee: Ophthalmic
• Clinical Trials: NCT03274986
• Supplement Type: Panel Track
• Supplement Reason: Change Design/Components/Specifications/Material
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

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.

• Approval Order: Approval Order
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling; Labeling Part 2