BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Lenses, Soft Contact, Extended Wear

    PMA: N18033 · Supplement: S035 · Decision Apr 12, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56

    Basic Information

    Device Name
    Lenses, Soft Contact, Extended Wear
    Trade Name
    ACUVUE 2 COLORS BRAND (ETAFILCON A) CONTACT LENS WITH UV BLOCKER
    PMA Number
    N18033
    Supplement Number
    S035
    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
    April 12, 2001
    Date Received
    January 29, 2001
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR AN ETAFILCON A SOFT (HYDROPHILIC) CONTACT LENS FOR EXTENDED WEAR WITH UV BLOCKER AND THE FOLLWOING LISTED COLOR ADDITIVES: IRON OXIDE BLACK, IRON OXIDE BROWN, IRON OXIDE RED, IRON OXIDE YELLOW, TITANIUM DIOXIDE, PHTHALOCYANINATO (2-) COPPER, PHTHALOCYANINE GREEN AND VAT ORANGE 1. THE DEVICE WILL BE MARKETED WITH THE FOLLOWING TRADE NAMES AND INDICATNIONS: THE ACUVUE (R) 2 COLOURS CONTACT LENSES ARE INDICATED FOR DAILY WEAR TO ENHANCE OR LATER THE APPARENT COLOR OF THE EYE AND/OR FOR THE CORRECTION OF REFRACTIVE AMETROPIA (MYOPIA AND HYPEROPIA) IN APHAKIC OR NON-APHAKIC PERSONS WITH NON-DISEASED EYES WHO MAY HAVE 1.00D OR LESS OF ASTIGMATISM. THE ACUVUE(R) 2 COLOURS (ETAFILCON A) SOFT (HYDROPHILIC) BIFOCAL CONTACT LENS IS INDICATED FOR DAILY WEAR FOR THE CORRECTION OF DISTANCE AND NEAR VISION IN PRESBYOPIC, APHAKIC OR NON-APHAKIC PERSONS WITH NON-DISEASED EYES WHO MAY HAVE 0.75D OF ASTIGMATISM OR LESS. THE ACUVUE(R) 2 COLOURS (ETAFILCON A) SOFT (HYDROPHILIC) TORIC CONTACT LENS IS INDICATED FOR DAILY WEAR FOR THE CORRECTION OF VISUAL ACUITY IN APHAKIC OR NON-APHAKIC PERSONS WITH NON-DISEASED EYES THAT ARE HYPEROPIC OR MYOPIC AND MAY HAVE 10.00D OF ASTIGMATISM OR LESS. THE ACUVUE(R) 2 COLOURS (ETAFILCON A) SOFT (HYDROPHILIC) TORIC-BIFOCAL CONTACT LENS IS INDICATED FOR DAILY WEAR FOR THE CORRECTION OF DISTANCE AND NEAR VISION IN PRESBYOPIC APHAKIC OR NON-APHAKIC PERSONS WITH NON-DISEASED WHO MAY HAVE 10.00D OR ASTIGMATISM OR LESS. ACUVUE(R) 2 COLOURS UV BLOCKING CONTACT LENSES HELP PROTECT AGAINST TRANSMISSINO OF HARMFUL UV RADIATINO TO THE CORNEA AND INTO THE EYE. THE ACUTVUE(R) 2 COLOURS CONTACT LENSES MAY BE PRESCRIBED FOR DAILY WEAR. EYE CARE PRACTITIONERS MAY PRESCRIBE THE LENSES EITHER FOR SINGLE-USE DISPOSABLE WEAR OR FREQUENT/PLANNED REPLACEMENT WEAR WITH CLEANING, DISINFECTION AND SCHEDULED REPLACEMENT (SEE "WEARING SCHEDULE".) WHEN PRESCRIBED FOR FREQUENT/PLANNED REPLACEMENT WEAR, THE LENSES MAY BE DISINFECTED USING A CHEMICAL DISINFECTIO

    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