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    K Number
    K073184
    Device Name
    BOSTON RGP LENSES WET SHIPPED IN BOSTOM SIMPLUS MULTI-ACTION SOLUTION AND STORED FOR UP TO 30 DAYS
    Manufacturer
    BAUSCH & LOMB, INC.
    Date Cleared
    2008-02-21

    (100 days)

    Product Code
    HQD
    Regulation Number
    886.5916
    Type
    Abbreviated
    Panel
    Ophthalmic
    Reference & Predicate Devices
    K002025
    Why did this record match?
    Device Name :

    BOSTON RGP LENSES WET SHIPPED IN BOSTOM SIMPLUS MULTI-ACTION SOLUTION AND STORED FOR UP TO 30 DAYS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    BOSTON XO (hexafocon A), BOSTON EO (enflufocon B), BOSTON ES (enflufocon A), BOSTON 7 (satafocon A), and BOSTON RXD (itabisfluorofocon A RGP Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, astigmatism, and presbyocia) in aphakic and not-aphakic persons with non-diseased eyes. The lens may be disinfected using a chemical disinfecting system only.

    BOSTON IV (itafocon B), BOSTON II (itafocon A) RGP Contact Lenses are indicated for daily wear for the correction of visual acuity for non-aphakic persons with myopia, hyperopia, or keratoconus and for the correction of corneal astigmatism up to 4.00 diopters. The lens is disinfected using a chemical (not heat) disinfection system recommended in the labeling.

    Device Description

    BOSTON RGP Contact Lenses are composed of silicone acrylate or fluoro silicone acrylate copolymers wet shipped in Boston SIMPLUS® Multi-Action Solution and stored up to 30 days.

    BOSTON SIMPLUS® Multi-Action Solution, a sterile, aqueous, buffered solution that contains poloxamine, hydroxyalky phosphonate, boric acid, sodium borate, sodium chloride, hydroxypropylmethyl cellulose, Glucam and preserved with polyaminopropyl biguanide (0.0005%), chlorhexidine gluconate (0.003%).

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and the study details for the Bausch & Lomb BOSTON RGP Lenses wet-shipped in BOSTON SIMPLUS® Multi-Action Solution:

    Acceptance Criteria and Device Performance

    Acceptance CriteriaReported Device Performance
    Stability of physical and optical propertiesTesting demonstrated stability as to physical and optical properties in accordance with ISO 11987:1997 Ophthalmic Optics - Determination of Shelf-life and WI0523 GP Lens Wet Packaging Qualification Procedures. Results support a 30-day shelf-life.
    Bioburden levelsBioburden levels were below the required minimum cfu values (
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