BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Extended Depth Of Focus Intraocular Lens

    PMA: P930014 · Supplement: S136 · Decision Jun 22, 2021
    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 Intraocular Lens (IOL)
    PMA Number
    P930014
    Supplement Number
    S136
    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
    June 22, 2021
    Date Received
    March 26, 2021
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval to increase the spherical power range for the AcrySof IQ Vivity Extended Vision Intraocular Lenses (IOLs), AcrySof IQ Vivity Extended Vision Toric IOLs, AcrySof IQ Vivity Extended Vision UV Absorbing IOLs, and AcrySof IQ Vivity Extended Vision UV Absorbing Toric IOLs from 15 D to 25 D to 10 D to 30 D; and to add a higher cylindrical power toric model to the AcrySof IQ Vivity™ Extended Vision Toric IOLs (Model DFT615) and AcrySof IQ Vivity Extended Vision UV Absorbing Toric IOLs (Model DAT615).

    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