Part Number: PIB01054
Page 3 of 18
Revision: A
Revision Date: June 2020
1. INTRODUCTION
The stenfilcon A Soft (hydrophilic) Contact Lenses are soft lenses. They are made from a "water-loving"
(hydrophilic) material that has the ability to absorb water, making the lens soft and flexible.
The stenfilcon A soft (hydrophilic) lenses are indicated for single use daily disposable wear. As prescribed
for single use daily disposable wear, once removed, they are to be discarded. They are not intended to be
cleaned and disinfected. You should always have replacement lenses or glasses available.
The information and instructions contained in this booklet apply only to stenfilcon A, stenfilcon A Toric,
stenfilcon A Multifocal, and stenfilcon A Multifocal Toric soft (hydrophilic) contact lens, referred to as your
contact lenses. For your eye health, it is important to wear your lenses as prescribed by your Eye Care
Practitioner. It is also important to keep your Eye Care Practitioner fully aware of your medical history. Your
Eye Care Practitioner will tailor a total program of care based on your specific needs. He or she will review
with you all instructions for lens handling, including how to safely and easily open the package. You will
receive instruction on how to properly insert and remove lenses. This booklet will reinforce those
instructions. Discard and replace your contact lenses with a new sterile pair, as prescribed by your Eye
Care Practitioner.
Please refer to the Section 13, GLOSSARY OF TECHNICAL TERMS, for definitions of medical/technical
terms used in this booklet.
1.1.
Benefits
Contact lenses provide vision correction.
If you lead an active lifestyle, contacts can provide:
•
close to natural vision.
•
excellent peripheral vision for sports and driving.
•
advantages for athletes and those with an active lifestyle.
If you work or play in an environment in which glasses are not an option, contact lenses are an alternative.
If you prefer the way you look without glasses, contact lenses can provide ease, and convenience.
1.2.
Risks
Wearing contact lenses puts you at risk of several serious conditions including eye infections and corneal
ulcers. These conditions can develop very quickly and can be very serious. In rare cases, these conditions
can cause blindness. Other risks of contact lenses include pink eye (conjunctivitis), corneal abrasions and
eye irritation. For further detail, see Section 4, WARNINGS, and Section 6, ADVERSE REACTIONS.
2. WEARING RESTRICTIONS AND INDICATIONS
Aspherical: Stenfilcon A ASPHERE Soft Contact Lenses are indicated for the correction of ametropia
(myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes in powers from -
20.00D to +20.00D diopters. The lenses may be worn by persons who exhibit astigmatism of -2.00 diopters
or less that does not interfere with visual acuity.
1
Contact Lens Comfort ,Contact Lens Council, http://www.contactlenscouncil.org/scon-comfort.htm
2
US FDA CDRH Contact Lens Risks Page, http://www.fda.gov/cdrh/contactlenses/risks.html
