BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Extended Depth Of Focus Intraocular Lens

    PMA: P210005 · Supplement: S011 · Decision Aug 4, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Extended Depth Of Focus Intraocular Lens
    Trade Name
    IC-8 Apthera Intraocular Lens (IOL)
    PMA Number
    P210005
    Supplement Number
    S011
    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
    August 4, 2025
    Date Received
    July 21, 2025
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    approval for a change to the address block of your labeling for the IC-8 Apthera IOL to align with other IOLs in the Bausch & Lomb portfolio

    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