BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Lenses, Soft Contact, Extended Wear

    PMA: P890023 · Supplement: S013 · Decision Mar 11, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56

    Basic Information

    Device Name
    Lenses, Soft Contact, Extended Wear
    Trade Name
    BIOMEDICS UV ASPHERE (OCUFILCON D) CONTACT LENSES FOR EXTENDED WEAR (UP TO 7 DAYS/6 NIGHTS OF EXTENDED WEAR)
    PMA Number
    P890023
    Supplement Number
    S013
    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
    March 11, 2002
    Date Received
    January 18, 2002
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR BIOMEDICS UV ASPHERE (OCUFILCON D) CONTACT LENSES INDICATED FOR EXTENDED WEAR (UP TO 7 DAYS/ 6 NIGHTS). THE SPONSOR ALSO REQUESTED APPROVAL OF THE SUBJECT DEVICES TO INCLUDE A STATEMENT THAT THE UV ABSORBING CONTACT LENSES HELP TO PROTECT AGAINST TRANSMISSION OF HARMFUL UV RADIATION TO THE CORNEA AND INTO THE EYE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME REFERENCED ABOVE WITH THE FOLLOWING INDICATION: THE BIOMEDICS UV ASPHERE (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENSES ARE INDICATED FOR THE CORRECTION OF VISUAL ACUITY IN PERSONS WITH NOT-APHAKIC, NON-DISEASED EYES WHICH MANIFEST MYOPIA (NEARSIGHTEDNESS), HYPEROPIA (FARSIGHTEDNESS) AND ASTIGMATIC CORRECTION LOWER THAN -2.00 DIOPTERS THAT DOES NOT INTERFERE WITH VISUAL ACUITY. THE BIOMEDICS UV ASPHERE (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENSES MAY BE PRESCRIBED FOR DAILY WEAR OR EXTENDED WEAR. FOR EXTENDED WEAR, THE LENS MAY BE PRESCRIBED FOR UP TO 7 DAYS/6 NIGHTS BETWEEN REMOVALS FOR CLEANING AND DISINFECTION; OR FOR DISPOSABLE WEAR AS DIRECTED BY THE EYE CARE PRACTITIONER. THE BIOMEDICS UV ASPHERE (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENSES MAY BE PRESCRIBED FOR SINGLE USE DISPOSABLE WEAR OR FOR SCHEDULED REPLACEMENT WEAR, WITH CLEANING, DISINFECTION, AND SCHEDULED REPLACEMENT. WHEN PRESCRIBED FOR SCHEDULED REPLACEMENT THE LENS MAY BE DISINFECTED USING A CHEMICAL (NOT HEAT) OR HYDROGEN PEROXIDE DISINFECTING SYSTEM. THE BIOMEDICS UV ASPHERE (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENSES HELP PROTECT AGAINST TRANSMISSION OF HARMFUL UV RADIATION TO THE CORNEA AND INTO THE EYE.

    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