BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Intraocular Lens

    PMA: P980040 · Supplement: S176 · Decision Mar 11, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Research PMA P980040 in seconds

    The Research Assistant summarizes PMA approval history, supplements and related safety signals — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    Intraocular Lens
    Trade Name
    TECNIS PureSee IOL, Model DEN00V TECNIS PureSee Toric II IOLs, Model DET150, DET225, DET300, DET375
    PMA Number
    P980040
    Supplement Number
    S176
    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
    March 11, 2026
    Date Received
    July 31, 2025
    Supplement Type
    Panel Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N
    Docket Number
    26M-2542

    Advisory Committee Statement

    Approval for the TECNIS SIMPLICITY™ Delivery System is used to fold and assist in inserting the TECNIS PureSee™ IOL, which is indicated for primary implantation for the visual correction of aphakia in adult patients with less than 1 diopter of pre-existing corneal astigmatism in whom a cataractous lens has been removed. The lens mitigates the effects of presbyopia by providing an extended depth of focus. Compared to an aspheric monofocal IOL, the TECNIS PureSee™ IOL provides improved intermediate visual acuity, while maintaining comparable distance visual acuity. The lens is intended for capsular bag placement only. The TECNIS SIMPLICITY™ Delivery System is used to fold and assist in inserting the TECNIS PureSee™ Toric II IOLs, which are indicated for primary implantation for the visual correction of aphakia and for reduction of refractive astigmatism in adult patients with greater than or equal to 1 diopter of preoperative corneal astigmatism in whom a cataractous lens has been removed. The lenses mitigate the effects of presbyopia by providing an extended depth of focus. Compared to an aspheric monofocal IOL, the TECNIS PureSee™ Toric II IOLs provide improved intermediate visual acuity, while maintaining comparable distance visual acuity. The lenses 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
    HQL Intraocular Lens