6.7.10

Are Circle Lenses Safe?

With the recent hype over the danger of circle lenses I have a few points of my own to make. The New York Times and ABC news are all hyping the circle lenses up to be super dangerous.

They do nothing to say why they are different from normal contacts, what theyre made out of, and neglect to mention the approval by the KFDA.

I think if you are going to attack the circle lenses you should attack the materials its made with
Turns out the material listed on my CL vials is surprise! the same one used on other lenses
Its called Phema which is....

"a polymer that forms a hydrogel in water. It was invented by Drahoslav Lim for use in soft contact lenses. Copolymers of pHEMA are still widely used today.
pHEMA functions as a hydrogel by rotating around its central carbon. In air, the non-polar methyl side turns outward, making the material brittle and easy to grind into the correct lens shape. In water, the polar hydroxyethyl side turns outward and the material becomes flexible. Pure pHEMA yields lenses that are too thick for sufficient oxygen to diffuse through, so all contact lenses that are pHEMA based are manufactured with copolymers that make the gel thinner and increase its water of hydration.[1] These copolymer hydrogel lenses are often suffixed "-filcon", such as Methafilcon, which is a copolymer of hydroxyethyl methacrylate and methyl methacrylate."


What I cant find out is if the lenses are made with pure phema since it is only listed as phema.
My candy-con lenses say 45% Polyhema 55% Water. Geo says 62% Phema 38% Water.
Just means that the lenses with the higher phema content shouldn't be worn as long due to the decreased oxygen, which any knowledgeable circle lens wearer would know.
Im not sure if any of the lenses are made with a -filicon derivative of phema, but they are made with a USFDA approved substance.

Here is a gov't article about cleaning polyhema lenses


According to the University of Washington Engineered Biomaterials:
"Poly(HEMA)
Poly(hydroxyethyl methacrylic) acid, or poly(HEMA), is one of the most important hydrogels in the biomaterials world since it has many advantages over other hydrogels. These include a water-content similar to living tissue, inertness to biological processes, resistance to degradation, permeability to metabolites, resistance to absorbtion by the body. It can be easily manufactured into many shapes and forms, and be easily sterilized. The most common example of poly(HEMA) is its use as contact lenses."

To sum it up, the materials Circle Lenses are made with are the same as other contact lenses.
The process used to make most circle lenses from what i understand is Lathe cutting which is pretty standard for making contact lenses, though a lot are being made by injection molds.
Circle lenses are packaged the same as regular lenses, in a buffered isotonic saline solution.

The lenses are not just willy-nilly manufactured and sold in the USA.  Legitimate brands are approved by many associations.  The KFDA approves lenses like Geo, Dueba, EOS, Vassen, etc.  The big name brands in Circle Lenses.  Many of these lenses also have ISO and CE certification.

Some notes about what ISO certification means.  ISO is the International Standards Organization, founded in 1947 in Geneva.  I took a quick peek at my EOS lens vial.  On the bottle it says "ISO 13485" . This means that the lenses adhere to ISO's medical device standard.  Here is a blurb fro ISO's website on this particular standard
"ISO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.






The primary objective of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. Because of these exclusions, organizations whose quality management systems conform to this International Standard cannot claim conformity to ISO 9001 unless their quality management systems conform to all the requirements of ISO 9001.
All requirements of ISO 13485:2003 are specific to organizations providing medical devices, regardless of the type or size of the organization.
If regulatory requirements permit exclusions of design and development controls, this can be used as a justification for their exclusion from the quality management system. These regulations can provide alternative arrangements that are to be addressed in the quality management system. It is the responsibility of the organization to ensure that claims of conformity with ISO 13485:2003 reflect exclusion of design and development controls.
If any requirement(s) in Clause 7 of ISO 13485:2003 is(are) not applicable due to the nature of the medical device(s) for which the quality management system is applied, the organization does not need to include such a requirement(s) in its quality management system.
The processes required by ISO 13485:2003, which are applicable to the medical device(s), but which are not performed by the organization, are the responsibility of the organization and are accounted for in the organization's quality management system."
"


And about CE, wikipedia says this:
"The CE marking (also known as CE mark) is a mandatory conformance mark on many products placed on the single market in the European Economic Area (EEA). The CE marking certifies that a product has met EU consumer safety, health or environmental requirements. CE stands for ConformitĂ© EuropĂ©enne, "European conformity" in French. By affixing the CE marking to a product, the manufacturer – on his sole responsibility – declares that it meets EU safety, health and environmental requirements."

And the lenses meet the standards set by the KFDA, and Korea is a leading nation.  Not a third world nation.  Not a nation known for producing knock offs and lead infested children's toys.  But a world leader in technology and economically.  Surely they wouldn't approve something so unsafe for their people?  And where are all the blind Korean women from using circle lenses?

And is the KFDA any worse than the USFDA?  I think not.  Especially with big pharmacutical companies in cahoots with the FDA.  How many times have you heard of a drug being passed then later the USFDA saying "OOPS, This drug/device needs a blackbox label or revoked completely!"  Seriously?

All this hype about lenses being dangerous and the optometrist on the ABC News article who said you can go blind in 24 hours from circle lenses.  This risk, however small, is applicable to all contact lenses.  Not just the ones imported from Korea.

Now, a disclaimer, this does not mean ALL circle lenses are safe.  There are fakes out there.  Be cautious and buy from reputable sellers.  Obtain a prescription from a licensed optometrist  so you know your prescription, your base curve, if you have astigmatism, or if you have any conditions that prevent you from safely wearing contact lenses.

One thing different about circle lenses from regular contacts is the diameter, but this isn't really true. The circle lenses are the same diameter as clear lenses can be. There are also Sclera lenses that are USFDA approved adn those are a wopping 20mm in diameter. Sclera lenses cove the entire white of the eye.

Oh, and here is what the USFDA says about ALL CONTACT LENSES (its kinda scary but you don't see media watch dogs freaking out about regular contacts do we?)






"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.
You can not determine the seriousness of a problem that develops when you are wearing contact lenses. You have to get help from an eye care professional to determine your problem.
If you experience any symptoms of eye irritation or infection,
  • remove your lenses immediately and do not put them back in your eyes.
  • contact your eye care professional right way.
  • don't throw away your lenses. Store them in your case and take them to your eye care professional. He or she may want to use them to determine the cause of your symptoms.
  • report serious eye problems associated with your lenses to the FDA’s MedWatch reporting program.
Symptoms of Eye Irritation or Infection
  • discomfort
  • excess tearing or other discharge
  • unusual sensitivity to light
  • itching, burning, or gritty feelings
  • unusual redness
  • blurred vision
  • swelling
  • pain
Serious Hazards of Contact Lenses
Symptoms of eye irritation can indicate a more serious condition. Some of the possible serious hazards of wearing contact lenses are corneal ulcers, eye infections, and even blindness.
Corneal ulcers are open sores in the outer layer of the cornea. They are usually caused by infections. To reduce your chances of infection, you should:
  • Rub and rinse your contact lenses as directed by your eye care professional.
  • Clean and disinfect your lenses properly according to the labeling instructions.
  • Do not “top-off” the solutions in your case. Always discard all of the left over contact lens solution after each use. Never reuse any lens solution.
  • Do not expose your contact lenses to any water: tap, bottled, distilled, lake or ocean water. Never use non-sterile water (distilled water, tap water or any homemade saline solution). Tap and distilled water have been associated with Acanthamoeba keratitis, a corneal infection that is resistant to treatment and cure.
  • Remove your contact lenses before swimming. There is a risk of eye infection from bacteria in swimming pool water, hot tubs, lakes and the ocean
  • Replace your contact lens storage case every 3-6 months.
Other Risks of Contact Lenses 
Other risks of contact lenses include





  •  pink eye (conjunctivitis)


  • corneal abrasions


  • eye irritation"


 But of course, Negative hype always overpowers news of the facts so i dont expect this article to get anywhere




Edited 7/6/10 at 5:50pm to include better formatting, and a paragraph about the USFDA as suggested by Susan in my comments.

    17 comments:

    1. Well put, Angie. I surely hope that people aren't deterred from all this negative hype.

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    2. Nice article. I wish the major news outlets did a bit more investigative reporting instead of resorting to scare tactics alone.

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    3. If you have some free time i think you should emphasize that the US FDA is no better than the KFDA, if not worse due to their connection with the big pharmaceutical industry. It's almost a joke to wave around BUT THE FDA HASN'T APPROVED THEM YETT as a threat.

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    4. Thank you all for your feedback.

      Susan~ I understand you completely. How many times have you heard of a drug being passed through the USFDA then later get a blackbox warning or revoked (like that one painkiller a few years back). Or the USFDA not wanting to pass a drug (Plan B) because it could cause crazed sex cults of teenaged girls. Its almost a joke.

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    5. Hi Angie!
      Great post! I hated those news about circle lenses and comparison with lady gaga, ridiculous.
      Really, they have the KFDA approval and any news reports this.
      Well, the Korean manufactures have to talk about it =(
      I'm really sad about this =/

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    6. Hi Angie :)
      I'm a soompier and I saw you post this.
      I LOVE your post. It sums up everything that I would have said and more. I'm really pissed about them relating Circle lenses with lady Gaga, she didn't even wear them! I just hope that they won't ban them from us buying online, or have circle lens be really expensive.

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    7. soompier in support of awesome circle lenses!July 28, 2010 at 11:46 PM

      Hi Angie, I'm a soompier and I recently came across your post on Soompi and read your post here.

      I must say that it is full of awesomeness! And I'm not a circle lens user either! I just follow trends on Soompi to know what's going on in the world on the east side :) The news was a big joke. I was also annoyed at the whole Lady Gaga reference. They obviously didn't do their homework. Also, isn't it sad that they're reporting on such a thing when they could've used the time to report on something IMPORTANT? I thought that was quite ridiculous.

      Anyway, just sharing my thoughts.


      Awesome post once again!

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    8. As a fashionable female and contact user, I think it's downright SILLY fr themto downplay this product. There areman more dangrous and highy toxic products circling the market that are produced right here in America! Sunscreen for crying out loud has been proven to be highly carcinogenic, as well as some toothpaste brands, antipesperiants, and hair sprays. As for eye infections/eye dangers, you are correct!Wearing ANY sort of contact lens poses a risk to your occular health. So does wearing mascara, fake eyelashes, and glitter eyeshadows. No news on them though!

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    9. So true.. I've been wearing circle lenses since forever and I haven't gone blind! The knockoffs are the ones that could make u go blind. These lenses are no different than regular lenses, just need to wear them for a shorter time. But everyone knows that.. They say that b/c circle lenses are foreign and aren't that well known in the U.S. They're perfectly fine to wear!

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    10. Hi

      I read this post two times.

      I like it so much, please try to keep posting.

      Let me introduce other material that may be good for our community.

      Source: ISO 9001 requirements

      Best regards
      Henry

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    11. Surely, contact lenses are made for two things for protective/correction purposes and for fashion. Moreover, these lenses are safe. Specially those disposable lenses. However, according to Arizona eye care, excessive usage of contact lenses(using more hours than prescribe time) may lead into the list of risk given above. This post could not be written any better. A++!

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    12. This post only proves that the certification of quality management systems is important for all products in the market because it serves as a mark of excellence in quality. Nowadays, it's hard to earn the trust of consumers because almost everything can be made fake now. Having your products certified by an ISO 9001 registrar can easily break that wall of suspicion between you and your target market.

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    13. It's good that these products have gone through certification systems first before they were sold. I wonder what the fuzz about circle lens being dangerous was. I guess it really depends on people's eyes because I see some people wear lens and not have any reaction, and others wearing the same type of lens having some kind of allergic reaction. Well anyway, if they're following international standards, then I guess their safe to some extent.

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    14. If the KFDA approves it, why doesn't the U.S. FDA?? The primary concern is that the FDA can not be certain that foreign-made contacts are made from safe materials because the FDA cannot regulate manufacturers abroad despite the fact that the KFDA has stamped its approval on some of these well-known sellers (ie Geo). Because people are going to buy them anyway, I think the FDA here should permit companies like acuvue to make circle lenses in the U.S. to minimize the fears and risk.

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    15. What I have seen in many stories of circle lenses being dangerous is that many people say they slept in them, I believe most of the negative hype has been from people playing the blame game they dont want to admit that they were stupid for sleeping in them so instead blame the company like the woman who sued mcdonalds because the coffe burned her lap when she removed the lid. Also, nobody seems to care that ALL the same dangers apply to regular lenses as well.

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    16. I wore daily-wear soft contacts for 20 years, and have recently had to switch to disposables, because my optometrist couldn't get "my" lenses anymore.
      I have never - not even once - had any sort of eye infection during all the years I've worn contacts.
      I think that as long as you're careful to always follow instructions when handling your lenses, wearing contacts is not that risky.
      That said, I'd be very hesitant to wear "circle" lenses. For one thing, I already have large eyes, and would probably look like some bizarre type of insect if they looked any bigger. Aso, the lenses just look too overtly "plastic" for my taste.
      But, to each his/her own! ;)

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    17. Nice post, very informative. I read your all articles carefully, keep posting, also look here at very informative article: medical device regulations in korea

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