BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Extended Depth Of Focus Intraocular Lens

    PMA: P930014 · Supplement: S126 · Decision Feb 26, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16

    Basic Information

    Device Name
    Extended Depth Of Focus Intraocular Lens
    Trade Name
    AcrySof™ IQ Vivity™ Extended Vision, Toric Extended Vision, Extended Vision UV Absorbing, and Toric Extended Vision UV A
    PMA Number
    P930014
    Supplement Number
    S126
    Device Class
    FDA Class 3
    Product Code
    POE
    Generic Name
    Extended depth of focus intraocular lens
    Regulation Number
    886.3600
    Medical Specialty
    Ophthalmic
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    February 26, 2020
    Date Received
    August 9, 2019
    Supplement Type
    Panel Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N
    Docket Number
    20M-0986

    Advisory Committee 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.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    POE Extended Depth Of Focus Intraocular Lens