Contact Lenses

[cintyber.livejournal.com]

A heads up for everyone who bought or was thinking of buying decorative contact lenses
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/HomeHealthandConsumer/ConsumerProducts/ContactLenses/ucm270953.htm

Comments

[denimskater.livejournal.com]

The ones I saw for sale at the con were FDA-approved.

[cintyber.livejournal.com]

They are not cosmetics or over-the-counter merchandise. They are medical devices regulated by the Food and Drug Administration (FDA). Places that advertise them as cosmetics or sell them without a prescription are breaking the law.

http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm275069.htm

[denimskater.livejournal.com]

::dry:: why yes, I am so tied to convention that I would never, knowing and fully accepting the risks, break any law or guideline of the US government.

I also am overjoyed that in the link you provided, they don't link a single actual medical study, but they do use anecdotes and appeal to authority. It really, really sucks that the FDA voluntarily does exactly what quack medicine sites do, providing a lousy example for any skeptical consumers out there.

I understand you're saying this so people know the risks. I just wish that the links you provided actually discussed the risks in a manner useful to someone trying to actually understand them, as opposed to "y'all kids better not do this stuff, Dad says it's bad."

[cintyber.livejournal.com]

My big objection and why I am so upset about this is...she was selling to minors. Without parents standing there just sell them to kids who ran to the girls room to stick them in their eye.

Contacts are dangerous people get cysts and infections from them all the time but using ones that say FDA approved but are clearly being sold outside of the guidelines makes me question if they really are FDA approved.

[intuition-ist.livejournal.com]

yep, this...

it might well be dangerous, but I'd like to be better informed on the actual occurrence of actual visual difficulties, rather than the blanket authority tactic.

[cintyber.livejournal.com]

http://www.geteyesmart.org/eyesmart/eye-health-news/scary-lenses.cfm

[lucky-otter.livejournal.com]

I can't find any confirmation of your claim that selling them without a prescription is illegal. The FDA recommends strongly, in the page you linked, that you don't do so. It does not claim that it's illegal and I can't find any law to that effect.

[pierceheart.livejournal.com]

Wow, did you not read this on the linked page:
Buying Decorative Contact Lenses

You can buy contact lenses, including decorative contact lenses, from an eye care doctor, on the Internet or from a mail-order company. It's very important that you only buy contact lenses from a company that sells FDA-cleared or approved contact lenses and requires you to provide a prescription.

Anyone selling you contact lenses must get your prescription and verify it with your doctor. They should request not only the prescription, but the name of your doctor and their phone number. If they don't ask for this information they are breaking federal law and could be selling you illegal contact lenses.

[lucky-otter.livejournal.com]

I did read that. Doesn't look like a law or regulation to me. I would like to know what the actual law is.

[pierceheart.livejournal.com]

But what you actually wrote was
It does not claim that it's illegal and I can't find any law to that effect.

It does, in fact, on that very page, claim it is illegal.

Maybe you should have your eyes checked?

[lucky-otter.livejournal.com]

It's also quite unclear in its language - they *could* be selling me illegal contact lenses if they don't ask for that information? Is it illegal or not? Is it just that contacting my doctor for confirmation is the usual procedure and if they don't do that, they might be selling unapproved lenses? Or is it that they are *required* to contact my doctor?

[cintyber.livejournal.com]

On November 9, 2005, section 520(n) was added to the Federal Food, Drug, and Cosmetic Act (the Act) by Public Law 109-96 to establish that all contact lenses are devices under section 201(h) of the Act. Because all contact lenses are now regulated as devices, including decorative, non-corrective contact lenses intended only to change the normal appearance of the eye, all contact lenses must be the subject of a cleared premarket notification (510(k)) or an approved premarket approval application (PMA) before they may be legally marketed. Additional device authorities, such as the requirement that lenses be dispensed only upon a prescription order, also apply. This guidance explains how section 520(n) affects FDA’s regulation of non-corrective contact lenses intended to change the appearance or color of a normal eye for decorative use.

http://www.ftc.gov/os/2004/01/040130contactlensrulefrn.pdf

[eclecticmagpie.livejournal.com]

What on earth is "unclear" about this:

"Anyone selling you contact lenses must get your prescription and verify it with your doctor. They should request not only the prescription, but the name of your doctor and their phone number. If they don't ask for this information they are breaking federal law"