Description
CE 0459 Medical Device, Class IIa.
OPTIVE Fusion is an over-the-counter (OTC) ophthalmic product intended for use by individuals who may experience dryness, irritation, burning, discomfort, and/or any other dry eye symptoms and does not require specific training for application.
OPTIVE Fusion is intended to lubricate and moisturize the eye surface 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 the sensation of dryness, irritation, burning, discomfort, and/or any other symptoms caused by dry eye disease (DED) or environmental factors.
OPTIVE Fusion can:
- reduce eye discomfort, ocular dryness and ocular irritation;
- improve the clinical signs of dry eye disease and tear film stability.
OPTIVE Fusion is safe for general use on the ocular surface and can be used repeatedly as needed without any minimum time interval between two instillations.
OPTIVE Fusion is compatible with all types of contact lens materials (soft contact lenses and gas permeable rigid contact lenses).

How to use
Put 1 or 2 drops in each affected eye as needed.
Close after use.

Components
10 ml of solution contain: 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 eye injury, do not touch the dropper tip 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 indicated 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 the administration of ophthalmic products.
- Discontinue use of the product and consult a doctor if you experience eye pain, changes in vision, continuous redness or irritation of the eyes, or if the condition worsens.
- May cause transient blurred vision which may impair the ability to drive or operate machinery. The patient should wait until vision has cleared before driving or operating machinery.
- Boron has been associated with negative effects on reproduction in animals at high doses. The product contains 0.7% w/w boric acid and 0.2% w/w sodium borate decahydrate with a total boron exposure from boric acid and sodium borate decahydrate of less than 1 mg boron/day, which is lower than the permissible daily exposure for adults and children and significantly lower than levels that cause adverse effects in animals. Consult your doctor or healthcare specialist for medical advice regarding the use of the product during pregnancy or while breastfeeding.
- 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 edema, foreign body sensation in the eye, increased tearing, eye swelling;
- hypersensitivity.

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

Format
10 ml bottle.