BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Lenses, Soft Contact, Extended Wear

    PMA: P010019 · Decision Oct 11, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56

    Basic Information

    Device Name
    Lenses, Soft Contact, Extended Wear
    Trade Name
    FOCUS NIGHT AND DAY (LOTRAFILCON A) SOFT CONTACT LENSES
    PMA Number
    P010019
    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
    October 11, 2001
    Date Received
    March 21, 2001
    Expedited Review
    N
    Docket Number
    01M-0479

    Advisory Committee Statement

    APPROVAL FOR THE FOCUS NIGHT AND DAY (LOTRAFILCON A) SOFT CONTACT LENSES FOR EXTENDED WEAR. THE DEVICE WILL BE MARKETED WITH THE FOLLOWING TRADE NAMES AND INDICATIONS: FOCUS NIGHT AND DAY (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 AND WITH UP TO APPROXIMATELY 1.50 DIOPTERS OF ASTIGMATISM. FOCUS NIGHT AND DAY TORIC (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 WITH 6.00 DIOPTERS (D) OR LESS OF ASTIGMATISM. FOCUS NIGHT AND DAY PROGRESSIVES (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 READING ADDITION OF +3.00 DIOPTERS (D) OR LESS AND WHO MAY HAVE UP TO APPROXIMATELY 1.50 DIOPTERS OF ASTIGMATISM. THE LENSES MAY BE PRESCRIBED FOR EXTENDED WEAR FOR UP TO 30 NIGHTS OF CONTINUOUS WEAR, WITH REMOVAL FOR DISPOSAL, OR CLEANING AND DISINFECTION 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