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    LBL 00333 MedioCROSS M Directions for Use 1

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    m7med.1988
    CXL operation a another way

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    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd

    LBL 00333 MedioCROSS M Directions for Use 1

    Uploaded by

    m7med.1988
    0 views1 page
    CXL operation a another way

    Copyright

    © © All Rights Reserved

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    PDF, TXT or read online from Scribd

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    CXL operation a another way

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    0 views1 page

    LBL 00333 MedioCROSS M Directions for Use 1

    Uploaded by

    m7med.1988
    CXL operation a another way

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 1

    Instructions For Use

    MedioC
     ROSS M
    ®

    Riboflavin Solution for Corneal Cross-Linking


    For epithelium-off procedure

    Contents:
    - MedioCROSS M syringe (1) with dropping adapter (1) – Syringe filled with 3.0ml (~60 drops) MedioCROSS M

    Note to the Doctor: Note to the Patient:


    - FOR SINGLE USE ONLY - AFTER APPLICATION THE VISUAL ACUITY IS
    - FOR TOPICAL OPHTHALMIC USE ONLY TEMPORARILY REDUCED.
    - NO SIMULTANEOUS APPLICATION OF ANOTHER - DO NOT DRIVE, DO NOT USE ANY MACHINERY, AND
    THERAPEUTIC OPHTHALMIC MEDICATION WAIT UNTIL THE NORMAL VISUAL ACUITY HAS BEEN
    RESTORED.
    Composition (per 100 ml):
    Characteristics:
    - 0.1% Riboflavin
    - Riboflavin (vitamin B2) is a water-soluble yellow substance
    - Hydroxypropylmethylcellulose (HPMC)
    - Hydroxypropylmethylcellulose (HPMC) is a white powder
    - Sodium Chloride
    - Disodium hydrogenphosphate x 12 H2O
    - Sodium dihydrogenphosphate x 2 H2O
    - Water for injection

    Usage: Storage:
    1. After removal of the corneal epithelium, apply sufficient - Store in dark place
    MedioCROSS M to completely wet and cover the exposed - Storage temperature ≤ 25° C
    stroma at two-minute intervals for a total of up to 10
    - Discard solution 12 hours after opening outer package
    minutes.
    - See expiry date
    2. Check corneal thickness by means of ultrasound
    pachymetry. If corneal thickness is less than 325 µm - Sterile if package is not broken, do not use if package is
    corneal thickness must be increased by means of damaged
    MedioCROSS H (hypotonic riboflavin solution) to ensure - Do not remove from foil pouch prior to use
    endothelial safety.
    3. After reaching a corneal thickness of at least 325 µm Side effects: (adverse effects without specifying the frequency)
    radiation, start UV treatment.
    - Hypersensitivity reactions (burning) may occur temporarily.
    4. When radiation stops, clean eye with (chilled) saline These usually resolve after discontinuation.
    solution.
    5. Insert bandage contact lens. Possible risks: (without specifying the frequency)
    6. Apply antibiotic ointment.
    - Corneal staining
    Indications: - Keratitis by bacteria
    - Sterile infiltrates
    - Progressive keratoconus
    - Corneal opacity
    - Iatrogenic ectasia
    - Corneal oedema
    - Pellucid marginal degeneration
    - Stromal scarring
    - Inclusions
    Contraindications:
    - Epithelial healing problems Other information:
    - Corneal melting
    - MedioCROSS M is a sterile medical device (CE 0482).
    - Pregnancy
    - 1 syringe of MedioCROSS M is for use for one eye only.
    - Herpetic keratitis (UV can activate herpes)
    Any remaining solution should be discarded.
    - Rheumatic disorders
    - Use as directed. Medio-Haus Medizinprodukte GmbH
    - Known sensitivity against one of the ingredients cannot guarantee the warranted characteristics such as
    function, material properties or sterility if product is used in
    a manner that is not consistent with Usage described
    above, or if the product is reused.

    Manufacturer: 0482 Manufacturing LOT Best before


    .
    Medio-Haus Medizinprodukte GmbH
    Brunswiker Straße 50, 24105 Kiel, Germany See directions for use Single use only

    25°C
    Distributed by: Steam-sterilized Storage not over 25°C
    Avedro, Inc.
    201 Jones Road, 5th Floor West, Waltham, MA, 02451 USA Endpacked product sterilized
    Store in the dark LBL-00333 Rev C
    with Ethylene Oxide

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