Focusing on Contact Lens Safety
More than 30 million Americans use contact
lenses, according to the Contact Lens Council. In addition to offering
flexibility, convenience, and a "no-glasses" appearance,
"contacts" help correct a variety of vision disorders, including
nearsightedness, farsightedness, astigmatism, and poor focusing with reading
material.
But contact lenses also present potential
risks. "Because they are worn directly on the eye, they can lead to
conditions such as eye infections and corneal ulcers," says James Saviola,
M.D. He is the Ophthalmic and Ear, Nose and Throat Devices Network Leader in
the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological
Health (CDRH). "These conditions can develop very quickly and can be very
serious. In rare cases, they can lead to blindness."
Best strategies for reducing your risk of infection
involve proper hygiene, following recommended wearing schedules, using proper
lens care practices for cleaning, disinfecting and storing your lenses, and
having routine eye exams.
FDA regulates contact lenses through the
Federal Food, Drug, and Cosmetic Act. The agency also regulates contact
lenses—including those intended for vision correction and for decorative
purposes—as prescription devices, and has jurisdiction over contact lens
solution.
The Federal Trade Commission (FTC) regulates
device advertising and marketing practices that cause or are likely to cause
substantial consumer injury.
Types of
Contact Lenses
General
categories
● Soft Contact Lenses are comfortable and made
of flexible plastics that allow
oxygen to pass through to the cornea. Users get accustomed to wearing
them within several days. Most soft-contact wearers are prescribed some
type of frequent replacement schedule. An example of this is a schedule that
calls for the lenses to be replaced with new ones after two weeks of use.
oxygen to pass through to the cornea. Users get accustomed to wearing
them within several days. Most soft-contact wearers are prescribed some
type of frequent replacement schedule. An example of this is a schedule that
calls for the lenses to be replaced with new ones after two weeks of use.
● Rigid Gas Permeable (RGP) Lenses are durable,
resist deposit buildup, and
generally allow for clear, crisp
vision. They last longer than soft contacts,
and also are easier to handle and less likely to tear. However, they may take
a few weeks of getting used to.
and also are easier to handle and less likely to tear. However, they may take
a few weeks of getting used to.
Other types
● Extended Wear Contacts are good for overnight
or continuous wear ranging
from one to six nights, or up to 30 days. It's important for the eyes to have a
rest without lenses for at least one night following each scheduled removal.
from one to six nights, or up to 30 days. It's important for the eyes to have a
rest without lenses for at least one night following each scheduled removal.
● Disposable (Replacement Schedule) Contacts.
To FDA, “disposable” means
"to be used once and
discarded." However, some soft contacts referred to as
“disposable” by sellers are actually worn on a frequent replacement
schedule--for two weeks, for example--that calls for them to be disinfected
between uses.
“disposable” by sellers are actually worn on a frequent replacement
schedule--for two weeks, for example--that calls for them to be disinfected
between uses.
● Lenses Designed for "Ortho-K."
Orthokeratology (Ortho-K) is a lens-fitting
procedure that uses specially
designed RGP contact lenses to change the
curvature of the cornea to temporarily improve the eye's ability to focus.
It's primarily used for the correction of nearsightedness. The most common
type is overnight Ortho-K, and FDA requires that eye care professionals be
trained and certified before using them in their practices.
curvature of the cornea to temporarily improve the eye's ability to focus.
It's primarily used for the correction of nearsightedness. The most common
type is overnight Ortho-K, and FDA requires that eye care professionals be
trained and certified before using them in their practices.
● Decorative (Plano) Contacts. FDA has often
warned people about the risks
associated with wearing these lenses
without appropriate professional
involvement. They don't correct vision and are intended solely to change
the appearance of the eye.
involvement. They don't correct vision and are intended solely to change
the appearance of the eye.
Getting a
Prescription
When you get an eye exam, you have the right
to get a copy of your prescription. You can then use it at another vendor or to
order contact lenses on the Internet, over the phone, or by mail.
As per FTC regulations, a prescription should
contain sufficient information for a seller to completely and accurately fill
the prescription: examination date, date you received the prescription after a
contact lens fitting, expiration date, and the name, address, phone and fax
number of the prescribing professional.
The prescription should also offer
information about material and/or manufacturer, base curve or appropriate
designation, and diameter (when appropriate) of the prescribed contact lens.
Tips for
Buying
With a valid prescription, it is possible to
purchase contact lenses from stores, the Internet, over the phone or by mail.
But be extremely cautious when buying contacts from someone other than your eye
care professional.
Contact lenses are NOT over-the-counter
devices. Companies that sell them as such are misbranding the device and
violating FTC regulations by selling you contact lenses without having your
prescription.
Avoiding
problems
● Make sure your prescription is current. Don't
order with an expired
prescription, and don't stock up on lenses right before the prescription is
about to expire. If you haven't had your eyes checked within the last year or
two, you may have eye problems that you are not aware of, or your lenses
may not correct your vision well.
prescription, and don't stock up on lenses right before the prescription is
about to expire. If you haven't had your eyes checked within the last year or
two, you may have eye problems that you are not aware of, or your lenses
may not correct your vision well.
● Order from a supplier that you are familiar
with and know is reliable.
● Request the manufacturer's written patient
information for your contact
lenses. It will give you important
risk/benefit information and instructions
for use.
for use.
● Beware of attempts to substitute a different
brand than you presently have.
There are differences in the water
content and shape among the brands.
The correct choice of which lens is right for you should be based only on an
examination by your eye care professional.
The correct choice of which lens is right for you should be based only on an
examination by your eye care professional.
● Make sure that you get the exact brand, lens
name, power, sphere, cylinder
(if any), axis (if any), diameter,
base curve, and peripheral curves (if any)
noted on the prescription. If you think you've received an incorrect lens,
check with your eye care professional. Don't accept a substitution unless
your eye care professional approves it.
noted on the prescription. If you think you've received an incorrect lens,
check with your eye care professional. Don't accept a substitution unless
your eye care professional approves it.
Proper Care
Required
Contact lens users run the risk of infections
such as pink eye (conjunctivitis), corneal abrasions, and eye irritation. A
common result of eye infection is corneal ulcers, which are open sores in the
outer layer of the cornea. Many of these complications can be avoided through
everyday care of the eye and contact-lenses.
To reduce
your chances of infection
● Replace your contact lens storage case every
3-6 months.
● Clean and disinfect your lenses properly.
● Remove your contact lenses before swimming.
● Never reuse any lens solution. Always discard
all of the used solution after
each use, and add fresh solution to
your lens case.
● Avoid using non-sterile water (distilled
water, tap water and homemade
saline) on your lenses. It can be a
source of microorganisms that may cause
serious eye infections.
serious eye infections.
● Never use homemade saline solution, as tap
and distilled water are not
sterile.
● Never transfer contact lens solutions into
smaller travel size containers.
This can affect sterility and may
also leave you open to accidentally
applying a harmful liquid to your eyes.
applying a harmful liquid to your eyes.
● Never put your lenses in your mouth; saliva
is not sterile.
"Also, any lenses worn overnight
increase your risk of infection," says Saviola.
"This is because contact lenses stress
the cornea by reducing the amount of oxygen to the eye. They can also cause
microscopic damage to the surface of the cornea, making it more susceptible to
infection."
Never ignore symptoms of eye irritation or
infection that may be associated with wearing contact lenses. The symptoms
include discomfort, excess tearing or other discharge, unusual sensitivity to
light, itching, burning, gritty feelings, unusual redness, blurred vision,
swelling and pain.
If you
experience any of these symptoms
● Remove your lenses immediately and keep them
off.
● Get in touch with your eye care professional
immediately.
● Keep the lenses. They may help your eye care
professional determine the
cause of your symptoms.
cause of your symptoms.
● Report serious eye problems associated with
your lenses to the MedWatch
reporting program at http://www.fda.gov/Safety/MedWatch/default.htm
reporting program at http://www.fda.gov/Safety/MedWatch/default.htm
Decorative Contact Lenses
Every year, the approach of Halloween
heightens fears at FDA that consumers will harm their eyes with unapproved
decorative contact lenses. These are lenses that some people use to temporarily
change their eye color or to make their eyes look weird--perhaps giving them an
"eye-of-the-tiger" look.
"Although unauthorized use of decorative
contact lenses is a concern year-round, Halloween is the time when people may
be inclined to use them, perhaps as costume accessories," says Saviola.
The problem is not that people use
decorative, non-corrective lenses. It's that many go about it the wrong way,
which is dangerous.
Prescription
required
Just like their corrective counterparts,
decorative contacts--sometimes called plano, zero-powered or non-corrective
lenses--are regulated by FDA.
"What troubles us is when they are bought
and used without a valid prescription, without the involvement of a qualified
eye care professional, or without appropriate follow-up care," says
Saviola. "This can lead to significant risks of eye injuries, including
blindness."
FDA is aware that consumers without valid
prescriptions have bought decorative contact lenses from beauty salons, record
stores, video stores, flea markets, convenience stores, beach shops and the
Internet.
Recent legislation has made it illegal to
market decorative contact lenses as over-the-counter products.
Unauthorized contact lenses of all types
present risks to the eye that include corneal ulcers, corneal abrasion, vision
impairment, and blindness.
If you want
decorative contacts
● Get an eye exam from a licensed eye care
professional, even if you feel your
vision is perfect.
● Get a valid prescription that includes the
brand and lens dimensions.
● Buy the lenses from an eye care professional
or from a vendor who requires
that you provide prescription information for the lenses.
that you provide prescription information for the lenses.
● Follow directions for cleaning, disinfecting,
and wearing the lenses, and
visit your eye care professional for follow-up eye exams.
visit your eye care professional for follow-up eye exams.
Source: http://www.webmd.com/
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