BEUDAMED
    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

    Lenses, Soft Contact, Extended Wear

    PMA: P990085 · Decision Feb 16, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56

    Basic Information

    Device Name
    Lenses, Soft Contact, Extended Wear
    Trade Name
    VISTAKON (LENEFILCON A) SOFT (HYDROPHILIC) CONTACT LENS, CLEAR AND VISIBILITY TINTED WITH UV BLOCKER
    PMA Number
    P990085
    Device Class
    FDA Class 3
    Product Code
    LPM
    Generic Name
    Lenses, soft contact, extended wear
    Regulation Number
    886.5925
    Medical Specialty
    Ophthalmic
    Advisory Committee
    Ophthalmic
    Decision
    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    February 16, 2001
    Date Received
    December 20, 1999
    Expedited Review
    N
    Docket Number
    01M-0149

    Advisory Committee Statement

    THE VISTAKON SPHERICAL (LENEFILCON A) CONTACT LENS IS INDICATED FOR DAILY AND EXTENDED WEAR FOR THE CORRECTION OF REFRACTIVE AMETROPIA (MYOPIA AND HYPEROPIA) IN NOT-APHAKIC PERSONS WITH NON-DISEASED EYES. THE LENS IS INDICATED FOR DAILY WEAR IN APHAKIC PERSONS. THE LENS MAY BE WORN BY PERSONS WHO HAVE ASTIGMATISM OF 1.00 DIOPTER OR LESS WHICH DOES NOT INTERFERE WITH VISUAL ACUITY.THE VISTAKON BIFOCAL (LENEFILCON A) CONTACT LENS IS INDICATED FOR DAILY AND EXTENDED WEAR FOR THE CORRECTION OF DISTANCE AND NEAR VISION IN PRESBYOPIC NOT-APHAKIC PERSONS WITH NON-DISEASED EYES. THE LENS IS INDICATED FOR DAILY WEAR IN APHAKIC PERSONS. THE LENS MAY BE WORN BY PERSONS WHO HAVE ASTIGMATISM OF 1.00 DIOPTER OR LESS WHICH DOES NOT INTERFERE WITH VISUAL ACUITY.THE VISTAKON TORIC (LENEFILCON A) CONTACT LENS IS INDICATED FOR DAILY AND EXTENDED WEAR FOR THE CORRECTION OF VISUAL ACUITY IN NOT-APHAKIC PERSONS WITH NON-DISEASED EYES THAT ARE MYOPIC OR HYPEROPIC AND HAVE 10.00 DIOPTERS OR LESS OF ASTIGMATISM. THE LENS IS INDICATED FOR DAILY WEAR IN APHAKIC PERSONS.THE VISTAKON TORIC BIFOCAL (LENEFILCON A) CONTACT LENS IS INDICATED FOR DAILY AND EXTENDED WEAR FOR THE CORRECTION OF DISTANCE AND NEAR VISION IN PRESBYOPIC NOT-APHAKIC PERSONS WITH NON-DISEASED EYES THAT HAVE ASTIGMATISM OF 10.00 DIOPTERS OR LESS. THE LENS IS INDICATED FOR DAILY WEAR IN APHAKIC PERSONS....

    Classifications

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

    Product Code Device Name
    LPM Lenses, Soft Contact, Extended Wear