INDICATIONS AND IMPORTANT SAFETY INFORMATION

for daily disposable soft contact lenses (stenfilcon A, somofilcon A):

 

INDICATIONS:

CooperVision daily disposable soft contact lenses are prescription devices indicated for daily wear, single use vision correction as prescribed by an Eye Care Practitioner.  The lenses are intended for wear in persons with non-diseased eyes.

Daily disposable contact lenses are intended to be worn for one day and are not intended for cleaning or re-use.  On removal the lenses should be thrown away and a fresh pair used each day.

Daily wear lenses are not indicated for overnight wear, and patients should not wear lenses while sleeping.

 

IMPORTANT SAFETY INFORMATION:

PROBLEMS WITH CONTACT LENSES AND LENS CARE PRODUCTS COULD RESULT IN SERIOUS INJURY TO THE EYE. Patients should be cautioned that proper use and care of the contact lenses and lens care products, including lens cases, are essential for the safe use of these products. It is essential that patients follow their eye care practitioner’s directions and all labeling instructions for proper use of lenses and lens care products. Patients should fill their lens case with fresh solution every time they store lenses, and never re-use solution. Additionally, they should clean and rinse their lens case between uses as recommended by their eye care practitioner. Eye problems including corneal ulcers, can develop rapidly and lead to loss of vision

 

Who Should Not Use Soft Contact Lenses:

  • Do not use your contact lenses when any of the following conditions exist:
  • Acute and subacute inflammation or infection of the anterior chamber of the eye.
  • Any eye disease, injury, or abnormality that affects the cornea, conjunctiva, or eyelids.
  • Severe insufficiency of lacrimal secretion (dry eye).
  • Corneal hypoesthesia (reduced corneal 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 use of contact lens solutions.
  • Allergy to any ingredient, such as mercury or thimerosal, in a solution, which is to be used to care for any lens.
  • Any active corneal infection (bacterial, fungal, or viral).
  • If eyes become red or irritated.
  • The patient is unable to follow lens care regimen or unable to obtain assistance to do so.

 

WARNINGS AND PRECAUTIONS:

Handling Precautions:

  • Do not use if the sterile blister package is opened or damaged.
  • Always wash and rinse hands before handling lenses.  Do not get cosmetics, lotions, soaps, creams, deodorant, or sprays in the eyes or on the lenses. It is best to insert lenses before putting on makeup.  Water-based cosmetics are less likely to damage lenses than oil-based products.
  • Lens contamination may occur if you handle your lens with dirty hands.
  • Carefully follow the handling, insertion, removal, and wearing instructions prescribed by your Eye Care Practitioner.
  • Always handle lenses gently and avoid dropping them.
  • Never use tweezers or other tools to remove lenses from the lens container.  Pour the lens and packaging solution into your hand.
  • Do not touch the lens with fingernails.

Lens Wearing Precautions: 

  • Never wear your lenses beyond the period recommended by your Eye Care Practitioner.
  • If aerosol products such as hairspray are used while wearing lenses, be careful and keep eyes closed until the spray has settled.
  • Avoid all harmful or irritating vapors and fumes while wearing lenses.
  • Ask your Eye Care Practitioner about wearing the lenses during sporting activities.
  • Always discard lenses following the recommended replacement schedule prescribed by your Eye Care Practitioner.

Who Should Know That You Are Wearing Contact Lenses: 

  • Inform your doctor (health care practitioner) that you wear contact lenses.
  • Always inform your employer that you wear contact lenses.  Some jobs may require use of eye protection equipment or may restrict contact lens wear.
  • Always contact your Eye Care Practitioner before using any medicine in your eyes.

 

Other Topics to Discuss with Your Eye Care Practitioner: 

  • Follow-up visits are necessary to assure the continued health of your eyes.  You should be instructed to a recommended follow-up schedule.

What are Key Complications Associated With Contact Lens Wear?

  • Be aware that the following problems may occur when wearing contact lenses:
  • Your eyes may burn, sting, and/or itch or you may experience other eye pain.
  • Comfort may be less than when the lens was first placed on the eye.
  • There may be a feeling that something is in the eye such as a foreign body or a scratched area.
  • There may be excessive watering (tearing), unusual eye secretions or redness of your eye.
  • Reduced sharpness of vision (poor visual acuity).
  • Blurred vision, rainbows, or halos around objects, sensitivity to light (photophobia) or dry eyes may also occur if your lenses are worn continuously or for too long a time.

If you notice any of the above, you should:

  • Immediately remove the lenses.
  • If the discomfort or the problem stops, then look closely at the lens.
    • If the lens is in some way damaged, do not put the lens back on the eye.  You should discard the lens and insert a fresh lens on your eye.
    • If the problem continues, you should immediately remove the lenses and consult your Eye Care Practitioner.  You should keep the lens off the eye and seek immediate professional identification of the problem and prompt treatment to avoid serious eye damage.  Your Eye Care Practitioner will examine your eyes to be certain that a serious condition such as infection, corneal ulcer, neovascularization, or swelling of the colored part of the eye (iritis) is not present.

Eye problems, including corneal ulcers, can develop rapidly and lead to loss of vision.  Daily wear lenses are not indicated for overnight wear, and you should not wear lenses while sleeping.  Clinical studies have shown that the risk of serious adverse reactions is increased when these lenses are worn overnight.  Studies have shown that contact lens wearers who are smokers have a higher incidence of adverse reactions than nonsmokers.  If you experience eye discomfort, excessive tearing, vision changes, or redness of the eye, you should be instructed to immediately remove lenses and promptly contact your Eye Care Practitioner.

By prescription only.  Please reference the Patient Information Booklet for a complete listing of Indications and Important Safety Information.