By MEGAN GARVEY, LA TIMES STAFF WRITER
WASHINGTON -- All 15-year-old Robyn Rouse wanted when she bought a pair
of tinted contacts at a Cleveland video store last year was to change
her dark eyes to green to match an outfit for the night.

The cosmetic lenses, one of thousands of pairs sold on the black market
to fashion-conscious teenagers and preteens, nearly left her blind in
one eye. Even after a cornea transplant, her doctor says it is too soon
to say whether she will recover fully.

On the Internet, at flea markets, in beauty parlors and beach-side
kiosks, just about anyone who knows where to look—and who is unaware or
unafraid of the risks—can accessorize their eyes to match their mood or
their shirt, even mimic the look of a wild animal. The soft lenses come
in colors ranging from a basic baby blue to Liz Taylor lilac.

Doctors and public health officials say they are alarmed by the
increasing incidence of medical complications caused by contacts
designed not to correct eyesight, but simply to change eye color.
Although sales are supposed to be made by licensed vendors to buyers
holding a valid prescription, many clearly are not.

Concerned that the trend is putting local teens at risk, Los Angeles
County supervisors voted in July to step up efforts by the county's
consumer affairs and health departments to warn parents and teens of
potential dangers of buying contacts off the street instead of by
prescription. Similar efforts are underway from coast to coast.

But soon, it may become even easier—and perfectly legal—to bypass health
professionals and purchase cosmetic contacts over the counter.

According to people familiar with the matter, the Food and Drug
Administration's general counsel, Daniel E. Troy, sent a letter to the
director of the agency's Center for Devices and Radiological Health, Dr.
David Feigel, this month, signaling interest in deregulating cosmetic
contact lenses.

A decision on whether to shift tinted lenses, now regulated as medical
devices, to a category of goods that includes eye shadow, hair dye and
thigh cream could come as soon as today, sources said. The FDA exercises
far broader oversight of medical devices than it does of cosmetics.

That the FDA might be considering such a move has disturbed some
lawmakers and doctors, who say they already are struggling to provide
the public with adequate information about the risks of wearing
something in an eye without guidance from medical professionals.

The apparent behind-the-scenes push for looser restrictions is prompting
criticism from doctors who have treated patients, many of them young
people, for eye infections and injuries.

Dr. Gail Royal, a Myrtle Beach, S.C., ophthalmologist who dealt this
summer with a rash of problems caused by contact lenses purchased from
unregulated sources, said any move to relax regulations would be
"extremely foolish."

"This is a physical device placed in an eye. It rubs on the cornea, and
it can reduce the oxygen reaching the eye," Royal said. "The
repercussions of this are huge. When you let someone think it is an
inconsequential novelty, then they treat it with no respect."

The potential market for cosmetic contacts is massive. According to
eye-care industry estimates, more than 14 million Americans would be
interested in changing their eye color.

FDA spokeswoman Sharon Snyder said late last week that she was not
familiar with any discussion of changes in policy. She said the general
counsel's office, as a matter of policy, does not speak to reporters
about pending matters.

"All I can tell you is that the policy right now is that these are
prescription devices necessary for eye-care professionals to oversee,"
she said. "If a dispenser sells a contact lens without receiving a valid
prescription, it is a violation of the prescription use law."

A public calendar of FDA activities lists a June 10 meeting between the
agency's chief counsel, Troy, and representatives of Fashion Wear
Services Ltd., a British-based company that exclusively sells cosmetic
contact lenses.

The contact lens maker has threatened to sue the FDA over the existing
policy, officials familiar with the matter said.

Paul Hyman, a Washington-based attorney who represents Fashion Wear
Services, said he was "not at liberty" to discuss his client's case. He
said the firm was still waiting to hear from the FDA on the matter,
although he had been promised a response "weeks ago."

Other contact lens makers, including some leaders in the U.S. market,
said they support the current regulations, and were unaware of a push to
make cosmetic lenses available without a prescription.

Amanda Cancel, a spokeswoman for Atlanta-based CIBA Vision, said her
company has been sending "cease and desist" letters to any vendor it
discovers selling lenses without prescriptions.

Lenses sold without prescriptions appear to come from a variety of
sources. Some are major-label cosmetic contacts stolen from doctors'
offices. Some are sold from Internet sites that illegally promise "no
prescription needed." Some are unlabeled, and probably foreign-made.
Doctors say the latter group is especially worrisome because it is
impossible to know what, if any, quality controls were used in their
manufacture.

Contacts that do not correct vision—known in the industry as "zero
power" or "plano" lenses—carry the same risks as contacts that help
people see better, medical experts warn.

Concerns about the possible policy change have prompted Rep. Henry A.
Waxman (D-Los Angeles) to urge Health and Human Services Secretary Tommy
G. Thompson "to intervene personally and stop what is a legally unsound
and medically dangerous policy."

Waxman, in a letter dated today, warned that such a shift "would also
establish a precedent that could lead to the deregulation of many more
potentially hazardous prescription drugs and devices."

Dr. Thomas Steinemann, an ophthalmologist and director of the Eye Clinic
at Metro Health Medical Center Cleveland, said his experiences treating
teenage girls have only strengthened his belief that people who purchase
any kind of contact lenses should first visit a vision care
professional.

"A contact lens that just changes the color of your eye still has all
the risk factors associated with corrective lenses," Steinemann said.
"Soft contact lenses disrupt the normal physiology of the eye. They
interfere with oxygen flow. They disrupt the eye's surface, and they
also act as a reservoir for bacteria."

Contacts require proper care and storage to reduce the likelihood of eye
infections, doctors say. A major concern arising from the
eye-color-changing fad is the reportedly common practice of teens
swapping lenses with friends, an activity experts liken to sharing
toothbrushes. When teens share contacts, they also share body fluids,
increasing the odds of a variety of infections, the experts warn.

Medical professionals also note that even if someone has normal vision,
shapes and sizes of eyeballs differ, requiring contacts to be fitted to
the eye. That alone, they argue, makes over-the-counter sales too risky
to be allowed. Steinemann said he recently treated two teenage girls who
wore black-market contacts that were too tight for their eyes, causing
them severe pain.

For Robyn Rouse, the memory of how close she came to losing her eyesight
remains vivid.

Within hours of putting in the lenses she bought off the shelf of the
video store, she was in agony, her eyes running, sunlight unbearable.
The next day, her frightened mother took her to an emergency room, where
she was diagnosed with a serious bacterial infection.

For four days and four sleepless nights, nurses administered eyedrops
every 30 minutes to save her eyesight. This year, the teenager underwent
a cornea transplant to fix scarring caused by the infection. It will be
several months before her doctors can pronounce her out of danger.

Now she warns others at her high school about what happened to her. But
she says the message has fallen on deaf ears for all but her closest
friends.

"Most people I go to school with still wear them. It'd be like they just
wear them to put them in to match their clothes," she said. "They're
like me before this happened. I didn't think they'd mess me up."

Times staff writer David Willman contributed to this report.
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