OPTIVE FUSION OPHTHALMIC SOLUTION 10 ML BOTTLE

Description
Medical Device CE 0459, class IIa.
OPTIVE Fusion is an over-the-counter (OTC) ophthalmic product intended for use by people who may experience dryness, irritation, burning, discomfort and/or any other symptoms of dry eye and does not require specific training for application.
OPTIVE Fusion is intended to lubricate and moisturize the surface of the eye and is indicated to help provide temporary relief from dryness, irritation, burning, discomfort and/or any other symptoms caused by dry eye disease (DED) or environmental factors.
OPTIVE Fusion provides instant soothing relief from dryness, irritation, burning, discomfort and/or any other symptoms caused by dry eye disease (DED) or environmental factors.
OPTIVE Fusion can:
- reduce eye discomfort, dry eye and eye irritation;
- improve the clinical signs of dry eye disease and tear film stability.
OPTIVE Fusion is safe for use on the general ocular surface and can be used repeatedly as needed with no minimum time interval between two instillations.
OPTIVE Fusion is compatible with all types of lens materials (soft and rigid gas permeable contact lenses).

How to use
Place 1 or 2 drops in each affected eye as needed.
Reseal after use.

Components
10 ml of solution contains: sodium carboxymethylcellulose 0.5%, glycerin 0.9%, sodium hyaluronate 0.1%, boric acid 0.7%, sodium borate decahydrate 0.2%, erythritol, sodium citrate dihydrate, potassium chloride, calcium chloride dihydrate, magnesium chloride hexahydrate, purified water, hydrochloric acid or sodium hydroxide to adjust pH and is preserved with PURITE 0.01%.

Warnings
- Do not swallow the solution.
- To avoid any contamination or possible injury to the eye, do not touch the dropper to any surface, and avoid direct contact with the eye.
- Keep out of reach of children.
- Do not use if the solution changes color or becomes cloudy.
- Do not use after the expiry date shown on the product.
- Do not use if the package shows signs of tampering.
- Do not use the bottle if the seal on the neck of the bottle is broken before first use.
- Close the bottle tightly immediately after use.
- After 90 days from first opening, discard any remaining solution.
- Store at room temperature.
- Allow 5 minutes to pass between administration of ophthalmic products.
- Stop using the product and consult a doctor if you experience eye pain, changes in vision, continued redness or irritation of the eyes, or if the condition worsens.
- May cause temporary blurred vision that may impair the ability to drive or operate machinery. The patient should wait until the vision clears before driving or operating machinery.
- Boron has been associated with adverse reproductive effects in animals at high doses. The product contains 0.7% w/w boric acid and 0.2% w/w sodium borate decahydrate, with total boron exposure from boric acid and sodium borate decahydrate less than 1 mg boron/day, which is below the permissible daily exposure for adults and children and significantly below the levels that cause adverse effects in animals. Consult your physician or healthcare professional for medical advice regarding use of this product during pregnancy or while breastfeeding/lactation.
- Do not use if the package shows signs of tampering.

Side effects
Clinical studies and post-marketing experience with OPTIVE Fusion have identified the following undesirable side effects:
- eye pain, eye discharge, eye irritation, eyelid swelling, foreign body sensation in the eye, increased tearing, eye swelling;
- hypersensitivity.

Conservation
Store at room temperature.
Shelf life after opening: 90 days.

Format
10 ml bottle.