BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Lenses, Soft Contact, Extended Wear

    PMA: P010019 · Supplement: S003 · Decision Sep 27, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56

    Basic Information

    Device Name
    Lenses, Soft Contact, Extended Wear
    Trade Name
    O2 OPTIX (LOTRAFILCON B) AND NIGHT AND DAY (LOTRAFILCON A) SOFT CONTACT LENSES FOR EXTENDED WEAR
    PMA Number
    P010019
    Supplement Number
    S003
    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
    September 27, 2004
    Date Received
    June 8, 2004
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR 1) A MODIFICATION TO THE LOTRAFILCON A MATERIAL TO MARKET LOTRAFILCON B CONTACT LENSES WITH AN INDICATION FOR UP TO 6 NIGHTS OF EXTENDED WEAR; 2) INCORPORATION OF A LIGHT BLUE HANDLING TINT, COPPER PHTHALOCYANINE, TO BOTH THE LOTRAFILCON A AND LOTRAFILCON B LENS MATERIALS; AND 3) A LABELING CHANGE FOR LOTRAFILCON A LENSES TO ALLOW FOR USE WITH ENZYMATIC CLEANERS. THE LOTRAFILCON B LENS WILL BE MARKETED UNDER THE TRADE NAME O2 OPTIX (LOTRAFILCON B) SOFT CONTACT LENSES FOR EXTENDED WEAR AND IS INDICATED FOR THE FOLLOWING: O2 OPTIX (LOTRAFILCON B) SPHERICAL SOFT CONTACT LENSES ARE INDICATED FOR THE OPTICAL CORRECTION OF REFRACTIVE AMETROPIA (MYOPIA AND HYPEROPIA) IN PHAKIC OR APHAKIC PERSONS WITH NON-DISEASED EYES WITH UP TO APPROXIMATELY 1.50 DIOPTERS (D) OF ASTIGMATISM THAT DOES NOT INTERFERE WITH VISUAL ACUITY. O2 OPTIX TORIC (LOTRAFILCON B) SPHERICAL SOFT CONTACT LENSES ARE INDICATED FOR THE OPTICAL CORRECTION OF REFRACTIVE AMETROPIA (MYOPIA AND HYPEROPIA) IN PHAKIC OR APHAKIC PERSONS WITH NON-DISEASED EYES WITH UP TO 6.00 D OR LESS OF ASTIGMATISM. O2 OPTIX PROGRESSIVE (LOTRAFILCON B) SPHERICAL SOFT CONTACT LENSES ARE INDICATED FOR THE OPTICAL CORRECTION OF REFRACTIVE AMETROPIA (MYOPIA AND HYPEROPIA) AND/OR PRESBYOPIA IN PHAKIC OR APHAKIC PERSONS WITH NON-DISEASED EYES WHO MAY REQUIRE A READING ADDITION OF +3.00 D OR LESS AND WHO MAY HAVE UP TO APPROXIMATELY 1.50 D OF ASTIGMATISM. O2 OPTIX PROGRESSIVE TORIC (LOTRAFILCON B) SPHERICAL SOFT CONTACT LENSES ARE INDICATED FOR THE OPTICAL CORRECTION OF REFRACTIVE AMETROPIA (MYOPIA, HYPEROPIA, ASTIGMATISM, AND PRESBYOPIA) IN PHAKIC OR APHAKIC PERSONS WITH NON-DISEASED EYES. THE LENSES MAY BE WORN BY PERSONS WHO HAVE 0.75 TO 2.75 D OF REFRACTIVE AND/OR CORNEAL ASTIGMATISM. THE LENSES MAY BE PRESCRIBED FOR DAILY WEAR OR EXTENDED WEAR FOR UP TO 6 NIGHTS OF CONTINUOUS WEAR WITH REMOVAL FOR DISPOSABLE, OR CLEANING AND DISINFECTION (CHEMICAL, NOT HEAT) PRIOR TO REINSERTION, AS RECOMMENDED BY THE EYE CARE PROF.

    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