BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Intraocular Lens

    PMA: P090022 · Supplement: S011 · Decision Jun 11, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59

    Basic Information

    Device Name
    Intraocular Lens
    Trade Name
    SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS (PCIOL)
    PMA Number
    P090022
    Supplement Number
    S011
    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
    June 11, 2012
    Date Received
    March 14, 2012
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MODIFICATIONS TO THE OPTIC BODY SHAPE AND OVERALLDIAMETER OF YOUR SOFTEC HD LENS TO INTRODUCE A LENS WITH AN OVOID OPTIC AND OVERALL DIAMETER OF 12.50 MM AND CHANGES TO YOUR LABELING RELATED TO THE INTRODUCTION OF THE MODIFIED LENS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SOFTEC HDO AND IS INDICATED FOR THE REPLACEMENT OF THE HUMAN CRYSTALLINE LENS FOLLOWING PHACOEMULSIFICA- TION CATARACT REMOVAL IN ADULTS OVER THE AGE OF 21. THE LENS IS INDICATED FOR CAPSULAR BAG PLACEMENT.

    Classifications

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

    Product Code Device Name
    HQL Intraocular Lens