BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Intraocular Lens

    PMA: P190018 · Decision Jan 7, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59

    Basic Information

    Device Name
    Intraocular Lens
    Trade Name
    Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon Toric Aspheric Hydrophobic Acrylic Intraocular Lens
    PMA Number
    P190018
    Device Class
    FDA Class 3
    Product Code
    HQL
    Generic Name
    intraocular lens
    Regulation Number
    886.3600
    Medical Specialty
    Ophthalmic
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    January 7, 2020
    Date Received
    July 11, 2019
    Expedited Review
    N
    Docket Number
    20M-0108

    Advisory Committee Statement

    Approval for the Clareon and Clareon Toric Aspheric Hydrophobic Acrylic Intraocular Lens (IOL).Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL):The Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL) 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 in whom a cataractous lens has been removed. Clareon Toric Aspheric Hydrophobic Acrylic Intraocular Lens (IOL):The Clareon Toric Aspheric Hydrophobic Acrylic Intraocular Lenses (IOLs) are indicated for primary implantation in the capsular bag in the posterior chamber of the eye for visual correction of aphakia and pre-existing corneal astigmatism to reduce residual refractive cylinder and improve uncorrected distance vision in adult patients in whom a cataractous lens has been removed. Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL) with the AutonoMe Pre-loaded Delivery System:The Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL) 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 in whom a cataractous lens has been removed. Clareon Toric Aspheric Hydrophobic Acrylic Intraocular Lens (IOL) with the AutonoMe Pre-loaded Delivery System:The Clareon Toric Aspheric Hydrophobic Acrylic Intraocular Lenses (IOLs) are indicated for primary implantation in the capsular bag in the posterior chamber of the eye for visual correction of aphakia and pre-existing corneal astigmatism to reduce residual refractive cylinder and improve uncorrected distance vision in adult patients in whom a cataractous lens has been removed.

    Classifications

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

    Product Code Device Name
    HQL Intraocular Lens