BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Lenses, Soft Contact, Extended Wear

    PMA: P040045 · Decision Dec 20, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56

    Basic Information

    Device Name
    Lenses, Soft Contact, Extended Wear
    Trade Name
    VISTAKON (SENOFILCON A) CONTACT LENS, CLEAR AND VISIBILITY TINTED WITH UV BLOCKER
    PMA Number
    P040045
    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
    Decision Code
    APPR
    Decision Date
    December 20, 2005
    Date Received
    November 15, 2004
    Expedited Review
    N
    Docket Number
    05M-0504

    Advisory Committee Statement

    APPROVAL FOR THE VISTAKON (SENOFILCON A) CONTACT LENS, CLEAR AND VISIBILITY TINTED WITH UV BLOCKER. THE DEVICE IS INDICATED FOR USE AS FOLLOWS: THE VISTAKON (SENOFILCON A) SOFT CONTACT LENS (SPHERICAL) IS INDICATED FOR THE OPTICAL CORRECTION OF REFRACTIVE AMETROPIA (MYOPIA AND HYPEROPIA) IN PHAKIC OR APHAKIC PERSONS WITH NON-DISEASED EYES WHO HAVE 1.00D OR LESS OF ASTIGMATISM. THE VISTAKON (SENOFILCON A) MULTIFOCAL SOFT CONTACT LENS IS INDICATED FOR THE OPTICAL CORRECTION OF DISTANCE AND NEAR VISION IN PRESBYOPIC, PHAKIC OR APHAKIC PERSONS WITH NON-DISEASED EYES WHO MAY HAVE 0.75D OF ASTIGMATISM OR LESS. THE VISTAKON (SENOFILCON A) TORIC SOFT CONTACT LENS IS INDICATED FOR THE OPTICAL CORRECTION OF VISUAL ACUITY IN PHAKIC OR APHAKIC PERSONS WITH NON-DISEASED EYES THAT ARE HYPEROPIC OR MYOPIC AND MAY HAVE 10.00D OF ASTIGMATISM OR LESS. THE VISTAKON (SENOFILCON A) MULTIFOCAL-TORIC SOFT CONTACT LENS IS INDICATED FOR THE OPTICAL CORRECTION OF DISTANCE AND NEAR IN PRESBYOPIC PHAKIC OR APHAKIC PERSONS WITH NON-DISEASED EYES WHO MAY HAVE 10.00D OF ASTIGMATISM OR LESS. THE VISTAKON (SENOFILCON A) UV BLOCKING SOFT CONTACT LENS HELP PROTECT AGAINST TRANSMISSION OF HARMFUL UV RADIATION TO THE CORNEA AND INTO THE EYE. EYE CARE PROFESSIONALS MAY PRESCRIBE THE LENSES EITHER FOR SINGLE-USE DISPOSABLE WEAR OR FREQUENT/PLANNED REPLACEMENT WEAR WITH CLEANING, DISINFECTION AND SCHEDULED REPLACEMENT. WHEN PRESCRIBED FOR FREQUENT/PLANNED REPLACEMENT WEAR THE LENSES MAY BE CLEANED AND DISINFECTED USING A CHEMICAL DISINFECTION SYSTEM ONLY. VISTAKON (SENOFILCON A) CONTACT LENSES MAY BE PRESCRIBED FOR DAILY WEAR AND EXTENDED WEAR FOR UP TO 6 NIGHTS/7 DAYS OF CONTINUOUS WEAR. IT IS RECOMMENDED THAT THE CONTACT LENS WEARER FIRST BE EVALUATED ON A DAILY WEAR SCHEDULE. IF SUCCESSFUL, THEN A GRADUAL INTRODUCTION OF EXTENDED WEAR CAN BE FOLLOWED AS DETERMINED BY THE PRESCRIBING EYE CARE PROFESSIONAL.

    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