BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Lens, Intraocular, Toric Optics

    PMA: P030002 · Supplement: S027 · Decision May 20, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19

    Basic Information

    Device Name
    Lens, Intraocular, Toric Optics
    Trade Name
    TRULIGN TORIC POSTERIOR CHAMBER INTRAOCULAR LENS
    PMA Number
    P030002
    Supplement Number
    S027
    Device Class
    FDA Class 3
    Product Code
    MJP
    Generic Name
    LENS, INTRAOCULAR, TORIC OPTICS
    Regulation Number
    886.3600
    Medical Specialty
    Ophthalmic
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 20, 2013
    Date Received
    March 27, 2012
    Supplement Type
    Panel Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N
    Docket Number
    13M-0724

    Advisory Committee Statement

    APPROVAL FOR THE TRULIGN TORIC POSTERIOR CHAMBER INTRAOCULAR LENS (MODELS: AT50T, BL1AT AND BL1UT) AND TRULIGN TORIC CALCULATOR. THIS DEVICE IS INDICATED FOR PRIMARY IMPLANTATION IN THE CAPSULAR BAG OF THE EYE FOR THE VISUAL CORRECTION OF APHAKIA AND POSTOPERATIVE REFRACTIVE ASTIGMATISM SECONDARY TO REMOVAL OF A CATARACTOUS LENS IN ADULT PATIENTS WITH OR WITHOUT PRESBYOPIA WHO DESIRE REDUCTION OF RESIDUAL REFRACTIVE CYLINDER WITH INCREASED SPECTACLE INDEPENDENCE ANDIMPROVED UNCORRECTED NEAR, INTERMEDIATE AND DISTANCE VISION.

    Classifications

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

    Product Code Device Name
    MJP Lens, Intraocular, Toric Optics