BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Lenses, Soft Contact, Extended Wear

    PMA: P010019 · Supplement: S025 · Decision Nov 2, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56

    Basic Information

    Device Name
    Lenses, Soft Contact, Extended Wear
    Trade Name
    AIR OPTIX NIGHT & DAY AQUA (LOTRAFILCON A) SOFT CONTACT LENSES
    PMA Number
    P010019
    Supplement Number
    S025
    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
    November 2, 2011
    Date Received
    June 6, 2011
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A TRADE NAME CHANGE TO THE SPHERICAL (LOTRAFILCON A) SOFT CONTACT LENSES WITH WETTING AGENT (L% COPOLYMER 845) IN PACKAGE SALINE, AND THE ADDITION OF DESCRIPTIVE TEXT FOR SYMBOLS APPEARING ON THE CARTONS, EXCEPT THE RX SYMBOL USED FOR "PRESCRIPTION USE," AS WELL AS THE TRADE NAME CHANGES TO ALL THE LOTRAFILCON A LENS DESIGNS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE FOLLOWING TRADE NAMES: SPHERICAL - AIR OPTIX NIGHT & DAY AQUA; TORIC - AIR OPTIX NIGHT & DAY AQUA ASTIGMATISM; MULTIFOCAL - AIR OPTIX NIGHT & DAY AQUA MULTIFOCAL; AND MULTIFOCAL TORIC - AIR OPTIX NIGHT & DAY AQUA MULTIFOCAL TORIC AND IS INDICATED FOR THE FOLLOWING:AIR OPTIXC NIGHT & DAY AQUA (LOTRAFILCON A) 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 WHO HAVE 1.50 DIOPTERS OR LESS OF ASTIGMATISM. AIR OPTIX NIGHT & DAY AQUA FOR ASTIGMATISM (LOTRAFILCON A) SOFT CONTACT LENSES ARE INDICATED FOR THE OPTICAL CORRECTION OF REFRACTIVE AMETROPIA (MYOPIA AND HYPEROPIA) IN PHAKIC OR APHAKIC PERSONS WITH NON-DISEASED EYES WHO HAVE 6.00 DIOPTERS (D) OR LESS OF ASTIGMATISM.AIR OPTIX NIGHT & DAY AQUA MULTIFOCAL (LOTRAFILCON A) 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 READINGADDITION OF +4.00 DIOPTERS (D) OR LESS AND WHO HAVE 1.50 DIOPTERS OR LESS OF ASTIGMATISM...(SEE APPROVAL ORDER FOR ADDITIONAL STATEMENT DETIAL)

    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