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

[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"