Specialty and Custom Contact Lenses From Bausch + Lomb

Eye Care Important Safety Information

Important Safety Information for Gas Permeable and Customized Soft Contact Lenses

WARNINGS:

Patients should be advised of the following warnings pertaining to contact lens wear:

• Problems with contact lenses and lens care products could result in serious injury to the eye. It is essential that patients follow their eyecare practitioner’s directions and all labeling instructions for proper use of lenses and lens care products, including the lens case. Eye problems, including corneal ulcers, can develop rapidly and lead to loss of vision.
• Daily wear lenses are not indicated for overnight wear, and patients should be instructed not to wear lenses while sleeping. Clinical studies have shown that the risk of serious adverse reactions is increased when daily wear lenses are worn overnight.
• Studies have shown that contact lens wearers who are smokers have a higher incidence of adverse reactions than nonsmokers.
• If a patient experiences eye discomfort, excessive tearing, vision changes, or redness of the eye, the patient should be instructed to immediately remove lenses and promptly contact his or her eyecare practitioner.

CONTRAINDICATIONS:

Do not use when any of the following conditions exist:

• Acute or subacute inflammation or infection of the anterior chamber of the eye
• Any eye disease, injury or abnormality, other than keratoconus, PMD, that affects the cornea, conjunctiva or eyelids
• Severe insufficiency of lacrimal secretion (dry eye)
• Corneal hypoesthesia (reduced sensitivity), if not aphakic
• Any systemic disease that may affect the eye or be exaggerated by wearing contact lenses
• Allergic reactions of ocular surfaces or adnexa that may be induced or exaggerated by wearing contact lenses or using contact lens solutions
• Allergy to any ingredient in a solution which is to be used to care for contact lenses
• Any active corneal infection (bacterial, fungal or viral)
• Red or irritated eyes

ADVERSE EFFECTS:

The following problems may occur with the use of contact lenses:

• Eyes stinging, burning, itching, irritation or other eye pain
• Comfort is less than when the lens was first placed on the eye
• Feeling of something in the eye such as a foreign body, scratched area
• Excessive watering (tearing) of the eye
• Unusual eye secretions
• Redness of the eyes
• Reduced sharpness of vision (poor visual acuity)
• Blurred vision, rainbows, or halos around objects
• Sensitivity to light (photophobia)
• Dry eyes