BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Lenses, Soft Contact, Extended Wear

    PMA: P980006 · Supplement: S012 · Decision May 30, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56

    Basic Information

    Device Name
    Lenses, Soft Contact, Extended Wear
    Trade Name
    PUREVISION 2/PUREVISION 2 MULTI-FOCAL/PUREVISION 2 TORIC (BALAFILCON A) VISIBILITY TINTED CONTACT LENSES
    PMA Number
    P980006
    Supplement Number
    S012
    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
    May 30, 2008
    Date Received
    April 2, 2008
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR DECREASING THE CENTER THICKNESS OF THE PUREVISION LENS AND ADDING 0.3 WT% HYDROXYPROPYL METHYLCELLULOSE TO THE PACKING SOLUTION. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME PUREVISION 2 VISIBILITY TINTED CONTACT LENSES AND IS INDICATED FOR THE FOLLOWING APPROVED INDICATIONS FOR USE: VISION CORRECTION THE BAUSCH & LOMB PUREVISION 2 (BALAFILCON A) VISIBILITY TINTED CONTACT LENS IS INDICATED FOR DAILY WEAR OR EXTENDED WEAR FROM 1 TO 30 DAYS BETWEEN REMOVALS, FOR CLEANING AND DISINFECTION OR DISPOSAL OF THE LENS, AS RECOMMENDED BY THE EYE CARE PROFESSIONAL. THE LENS IS INDICATED FOR THE CORRECTION OF REFRACTIVE AMETROPIA (MYOPIA AND HYPEROPIA) IN APHAKIC AND/OR NOT-APHAKIC PERSONS WITH NON-DISEASED EYES, EXHIBITING ASTIGMATISM OF 2.00 DIOPTERS OR LESS, THAT DOES NOT INTERFERE WITH VISUAL ACUITY. THE LENS MAY BE PRESCRIBED FOR FREQUENT/PLANNED REPLACEMENT WEAR OR DISPOSABLE WEAR IN SPHERICAL POWERS RANGING FROM +8.00D TO ?20.00D WHEN PRESCRIBED FOR UP TO 30 DAYS OF EXTENDED WEAR AND FROM +20.00D TO ?20.00D FOR DAILY WEAR OR EXTENDED WEAR UP TO 7 DAYS. THE BAUSCH & LOMB PUREVISION 2 MULTI-FOCAL (BALAFILCON A) VISIBILITY TINTED CONTACT LENS IS INDICATED FOR DAILY WEAR OR EXTENDED WEAR FROM 1 TO 30 DAYS BETWEEN REMOVALS, FOR CLEANING AND DISINFECTION OR DISPOSAL OF THE LENS, AS RECOMMENDED BY THE EYE CARE PROFESSIONAL. THE LENS IS INDICATED FOR THE CORRECTION OF REFRACTIVE AMETROPIA (MYOPIA, HYPEROPIA AND ASTIGMATISM) AND PRESBYOPIA IN APHAKIC AND/OR NOT-APHAKIC PERSONS WITH NON-DISEASED EYES, EXHIBITING ASTIGMATISM OF UP TO 2.00 DIOPTERS OR LESS, THAT DOES NOT INTERFERE WITH VISUAL ACUITY. THE LENS MAY BE PRESCRIBED FOR FREQUENT/PLANNED REPLACEMENT WEAR OR DISPOSABLE WEAR IN SPHERICAL POWERS RANGING FROM +6.00D TO -18.00D WHEN PRESCRIBED FOR UP TO 30 DAYS OF EXTENDED WEAR AND FROM +20.00D TO ?20.00D FOR DAILY WEAR OR EXTENDED WEAR UP TO 7 DAYS WITH ADD POWERS RANGING FROM +0.75D TO +5.00D.. (SEE APPROVAL ORDER FOR ADDITIONAL INFORMATION)

    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