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510(k) Data Aggregation

    K Number
    K071236
    Device Name
    ALCON MULTI-PURPOSE SOLUTION
    Manufacturer
    ALCON, INC.
    Date Cleared
    2007-12-12

    (223 days)

    Product Code
    LPN
    Regulation Number
    886.5928
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALCON, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use in the daily cleaning, conditioning, rinsing, chemical (not heat) disinfection, and storage of silicone hydrogel contact lenses as recommended by your eye care practitioner.
    Device Description
    ALCON® Multi-Purpose Solution is a sterile, buffered, isotonic, aqueous solution containing sodium chloride, sodium borate, propylene glycol, sorbitol, edetate disodium, TETRONIC® 1304, hydroxypropyl guar and POLYQUAD® (polyquaternium-1) 0.00025% preservative.
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    K Number
    K040231
    Device Name
    INTELIPORT OCCLUDING DEVICE
    Manufacturer
    ALCON, INC.
    Date Cleared
    2004-07-13

    (162 days)

    Product Code
    LZU
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALCON, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The InteliPORT® Occluding Device is intended for use in patients experiencing dry eye symptoms such as redness, burning, reflex tearing, itching or foreign body sensations which can be relieved by occluding the lacrimal drainage system in order to increase tear volume. The InteliPORT® Occluding Device may be used in the treatment of dry eye syndrome and the dry eye components of various ocular surface diseases. Other patients that may benefit are: patients with arthritis, patients taking systemic or topical medications known to produce dry eyes, contact wearers who experience dry eye related problems, and patients who live in dry climates, or spend extended periods of time in low humidity environments (such as air conditioning). Topical eye drops may be more effective with punctal occlusion because tear drainage will be retarded, and tear breakup time extended.
    Device Description
    The InteliPORT® Occluding Device is designed to deliver a custom fit plug through the punctal opening to block tear drainage. The self-forming plug (Intelimer Occluding Material*) is heated and inserted through the punctal opening into the proximal canaliculus as a melted viscous liquid. It rapidly solidifies to conform to the shape of the ampulla and canaliculus. The InteliPORT® Occluding Device is composed of a transitional and continuous block of Intelimer Occluding Material (matrix) which is adequate for delivering two doses in a single patient use applicator and is provided in a sealed, sterilized package. The Intelimer Occluding Material is liquefied in the applicator by warming it a few degrees above body temperature via an internal 1.5 volt battery and a heating coil. The narrow applicator tip is then inserted into the punctal opening and the plunger is pushed to deliver the Intelimer Occluding Material. Once inside the duct, the material cools to form a customized plug that conforms to the shape of the individual's ampulla and canaliculus. The volume of material delivered, approximately 4-7 micro liters, is controlled so as to flow into the common ampulla and canaliculus. Restoration of patency may be accomplished by irrigation with warm sterile saline.
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    K Number
    K031193
    Device Name
    SOFT (HYDROPHILIC) CONTACT LENS CARE SOLUTION
    Manufacturer
    ALCON, INC.
    Date Cleared
    2003-07-03

    (78 days)

    Product Code
    LPN
    Regulation Number
    886.5928
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALCON, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use in the daily cleaning, removing protein deposits, rinsing, chemical (not heat) disinfection and storage of soft (hydrophilic) contact lenses as recommended by your eye care practitioner. OPTI-ONE® Multi-Purpose Solution (modified directions for use) can also be as a d:luent for OPTI-ZYME® Enzymatic Cleaner.
    Device Description
    OPTI-ONE® Multi-Purpose Solution is a sterile, buffered, isotonic, aqueous solution, containing borates, citrate, mannitol, and sodium chloride with Pationic® and Tetronic® surfactants and edetate disodium 0.05% and POLYQUAD® (polyquaternium-1) 0.0011% preservatives.
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