BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Lenses, Soft Contact, Extended Wear

    PMA: P010019 · Supplement: S021 · Decision Sep 9, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56

    Basic Information

    Device Name
    Lenses, Soft Contact, Extended Wear
    Trade Name
    CIBA VISION AIR OPTIX AQUA (LOTRAFILCON B) SOFT CONTACT LENSES
    PMA Number
    P010019
    Supplement Number
    S021
    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 9, 2011
    Date Received
    March 1, 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 (LOTRAFILCON B) SOFT CONTACT LENSES WITH WETTING AGENT IN PACKAGE SALINE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CIBA VISION AIR OPTIX AQUA (LOTRAFILCON B) AND IS INDICATED FOR THE FOLLOWING: CIBA VISION AIR OPTIX AQUA (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 OF ASTIGMATISM THAT DOES NOT INTERFERE WITH VISUAL ACUITY. CIBA VISION AIR OPTIX AQUA (LOTRAFILCON B) TORIC 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 DIOPTERS (D) OR LESS OF ASTIGMATISM. CIBA VISION AIR OPTIX AQUA (LOTRAFILCON B) MULTIFOCAL 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 REQUIRED A READING ADDITION OF +3.00 DIOPTERS (D) OR LESS AND WHO MAY HAVE UP TO APPROXIMATELY 1.50 DIOPTERS OF ASTIGMATISM. CIBA VISION AIR OPTIX AQUA (LOTRAFILCON B) MULTIFOCAL TORIC 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 10.00 DIOPTERS (D) OR LESS 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 DISPOSAL, OR CLEANING AND DISINFECTION (CHEMICAL, NOT HEAT) PRIOR TO REINSERTION, AS RECOMMENDED BY THE 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