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The Magic Cafe Forum Index » » Latest and Greatest? » » Alakazam presents "Biokinesis" by Berk Eratay (0 Likes) Printer Friendly Version

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daffydoug
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I kind of thought so!

Thanks!

So you like sick ideas like scaring the kiddies, too, eh?
The difficult must become easy, the easy beautiful and the beautiful magical.
paisa23
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I do I really do. I don't know I am a huge horror buff and just like that aspect.
daffydoug
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Good man!
The difficult must become easy, the easy beautiful and the beautiful magical.
cheekychap
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Quote:
On 2010-08-01 15:22, taoist wrote:
Quote:
On 2010-07-30 13:00, daffydoug wrote:
(Also, I'm curious, what happens after the life span ends. Does the product simply wear out, disintegrate, fall apart, or what?) Why is it not possible to manufacture this so that it will last a lifetime under good care?


They simply return to Hades after 6 months. ;>


How true is this about eyes??

FDA now considers all contact lens a medical device (this includes plano lenses) and can only be sold with the involvement of a Eye Care Professional.


Let's clarify exactly what the law is
and how it effects you:

Everyone's eyes are different. Correct? The law states that you must have a contact lens fitting on file with an eye care professional within the past year even if you do not need prescription lenses. This ensures that our stock theatrical lenses will fit you properly and that you have been instructed on how to care for contact lenses. C'mon guys... these are your EYES! So many things... bad, evil, things can happen to your vision if you wear lenses that don't fit properly or if you don't clean and care for them properly!!! Imagine buying a pair of shoes that were 3 sizes too small... and wearing them for an entire month! You could wreck your feet! Well, multiply that by 1000 and that's what it's like wearing contact lenses that don't fit!!

Even if you do not have an eye doctor you can still go and get a contact lens fitting! Even some Wal-Mart locations have a vision center and you can get a lens fitting for under $50 in most cases! This fitting is good for an entire year!
daffydoug
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Am I understanding this correctly: When I buy this effect the law commands me to go see an eye doctor???
The difficult must become easy, the easy beautiful and the beautiful magical.
cheekychap
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Quote:
On 2010-08-03 08:49, daffydoug wrote:
Am I understanding this correctly: When I buy this effect the law commands me to go see an eye doctor???


I'm unsure, but it looks that way in certain countries, or states, because everyones eyeballs are all different shapes, and sizes, and I wondered how this effect stands on peoples eyes who may not match up, which is a very important point to all, especially those intend on wearing them all day, as constant lens wear has been associated with corneal ulcers, which can lead rapidly to internal ocular infection
so it not to good, if this is a fact on the lenses being sold

heres a bit more write up on the FDA law, and quite interesting :-

Guidance for Industry, FDA Staff, Eye Care Professionals, and Consumers
Decorative, Non-corrective Contact Lenses
This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance.
Introduction

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.

FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
The Least Burdensome Approach

We believe we should consider the least burdensome approach in all areas of medical device regulation. This guidance reflects our careful review of the relevant scientific and legal requirements and what we believe is the least burdensome way for you to comply with those requirements. However, if you believe that an alternative approach would be less burdensome, please contact us so we can consider your point of view. You may send your written comments to the contact person listed in the preface to this guidance or to the CDRH Ombudsman. Comprehensive information on CDRH's Ombudsman, including ways to contact him, can be found on the Internet.
I. Background

FDA is aware of the distribution and use of non-corrective contact lenses that are used to change the normal appearance of the eye in a decorative fashion, such as with colors or designs (decorative contact lenses). Decorative contact lenses that do not have FDA premarket authorization have been marketed directly to consumers. Consumers have used such lenses without the benefit of a valid prescription.

Without a valid prescription, fitting, supervision, or regular check-ups by a qualified eye care professional, decorative contact lenses, like all contact lenses, can cause a variety of serious injuries or conditions. For example, lens wear has been associated with corneal ulcer, which can lead rapidly to internal ocular infection if left untreated. Uncontrolled infection can cause corneal scarring, which can lead to vision impairment, and in extreme cases, blindness or the loss of an eye. Other risks include conjunctivitis; corneal edema (swelling); allergic reaction; abrasion from poor lens fit; reduction in visual acuity, contrast sensitivity, and other visual complications that can interfere with driving and other activities.

Because of these risks, contact lenses, including decorative contact lenses that are non-corrective, are not safe for use except under the supervision of a practitioner licensed by law to direct the use of such devices. The Agency believes that these risks cannot be sufficiently controlled unless the wearer does the following under professional supervision:

* Obtains advice about using contact lenses;
* Has a valid prescription;
* Has the lenses fitted properly; and
* Remains under appropriate professional care for contact lens use.

II. How does recent legislation affect FDA’s regulation of contact lenses?

FDA has reviewed premarket notification submissions (510(k)s) under section 510(k) of the Act (21 U.S.C. 360(k)) and premarket approval applications (PMAs) under section 515 of the Act (21 U.S.C. 360(e)) for most corrective and non-corrective contact lenses marketed in the United States, including certain decorative contact lenses intended to change the appearance of a normal eye. All currently approved or cleared decorative contact lenses are legally marketed only as prescription devices (21 CFR 801.109). However, some non-corrective, decorative contact lenses have not been reviewed by FDA and are sold without a prescription. Although FDA had taken the position that contact lenses intended solely for decorative use may be regulated as cosmetics under section 201(i) of the Act, enactment of section 520(n) requires that all contact lenses be regulated as devices.

Thus, all contact lenses in commercial distribution, including decorative contact lenses that are non-corrective, require either a cleared 510(k), an approved PMA, or an exemption for investigational use (IDE). Without such premarket authorization by FDA, decorative contact lenses are adulterated under section 501(f)(1)(B) of the Act (21 U.S.C. 351(f)(1)(B)), and misbranded under section 502(o) of the Act (21 U.S.C. 352(o)).
III. Can manufacturers, importers, distributors, or retailers market decorative contact lenses as over-the-counter products?

No. Decorative contact lenses should not be marketed or made available to consumers by manufacturers, importers, distributors, or retailers as an over-the counter item. Manufacturers or initial importers should cease distribution of the devices and submit to FDA an appropriate premarket notification for clearance or application for approval if they intend to distribute any type of non-corrective contact lenses, including decorative lenses used to change the appearance of a normal eye. Guidance for 510(k) submissions for contact lenses is located at Premarket Notification (510(k)) Guidance Document for Daily Wear Contact Lenses. Contact lenses, including decorative, non-corrective contact lenses, are also subject to general controls of the Act, including the Quality System regulation (21 Code of Federal Regulations (CFR) Part 820), and other applicable device regulations and statutory requirements, including conformance with labeling requirements such as 21 CFR 801.109.
IV. Are manufacturers, importers, distributors, or retailers subject to inspection by FDA?

Yes. FDA has inspected several firms distributing decorative contact lenses and warned firms that selling decorative contact lenses without a valid prescription or proper labeling that includes information about the risks and proper instructions for safe use violates federal law. FDA has also alerted mass marketing firms and operators of on-line sites about the risks associated with decorative contact lenses distributed without appropriate eye care professional involvement.
V. How are imported lenses affected by FDA’s law?

A s devices, imported decorative contact lenses that do not comply with applicable premarket device requirements are subject to detention without physical examination under the procedures described in FDA’s Import Alert #89-08, “Detention without Physical Examination of Devices without Approved PMA’s or IDE’s and Other Devices not Equivalent or no 510(k)” (see also section 801 of the act, 21 U.S.C. 381). The import alert instructs FDA personnel and officials of the United States Customs Service to detain automatically all devices presented at the United States ports of entry that are in violation of federal law. Import Alert #89-08, can be accessed on the Internet.
VI. Can consumers still buy contact lenses used for decorative purposes only?

Yes, if there is a valid prescription. As when buying all contact lens, consumers should be seen by an eye care professional and obtain proper fitting and instructions for using a contact lens. These devices present significant risks of eye injuries, including blindness, if distributed without a valid prescription and the involvement of a qualified eye care professional and appropriate follow-up care.

More information for consumers on the use of decorative lenses can be found on FDA’s web site http://www.fda.gov/NewsEvents/Newsroom/ PressAnnouncements/2004/ucm108366.htm.
Marc Spelmann
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The laws regarding contact lenses vary all over the world. In the UK you can buy contact lenses off of Ebay and even Amazon. Also in the UK there is no age requirement or need to have an eye test..

HOWEVER...

We recommend that if you intend on doing this effect it's common sense to have an eye test first, it's common sense to have an eye test anyway. On the DVD we teach how to clean, care and use your gimmicks. The gimmicks are NOT regular. Without divulging to much info they are designed for this effect and are universal.

Berk states on the DVD that he has an eye test every year which we all should do anyway. But many of us, myself included neglect our eyes.

Whatever the laws are for your country, we advise you to follow them and use care and caution. We fully acknowledge that anything to do with your eyes is potentially dangerous and mention it constantly on the DVD and we do not encourage anyone to do this effect without full knowledge and understanding.

We will not sell this to under 18 year olds.

MS
It's not goodbye, just see you later...
cheekychap
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Great stuff, so the lenses are suited to fit all wearers, or can be used by all magicians without worry??,
but we should all get a check up anyway to be safe, my main concern was the lens sizes, and eyes being different ( same as wearing a smaller shoe sizes ), but these are a 1 fit size for all users who buy them??
paisa23
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There are gas stations in Louisiana that sell color contacts right next to the Bubble Gum. Wearing contacts without a doctor’s approval is just the precaution that is taken. Just like the Surgeon General on the side of Cigs. Anything that involves your eyes can have a chance of injuring something. If you feel that you should get your eyes checked out prior to buying this effect, understand that the test ALONE will be more then the effect. Also I’m pretty sure that if you told your doctor that the contacts you are purchasing are a little different than normal contacts, that you will be training your muscles to hold them and release them I’m almost positive that he would advise against it. So is there laws to buying contacts, yeah there is. Even on line when you order contact, they ask for Dr.s name, practice and contact number. I have owned at least 12 different set of contacts in my life and they have yet to Call, Dr. Felangie(MADE UP NAME FROM SHOW FRIENDS) and the dr.s number (HONESTLY) 867-5309... Am I right for doing this? Maybe, but that is another subject that doesn’t pertain to this.

ON a side note, every time I see this topic on the top of the page I’m hoping to go in to read, THEY ARE GOING OUT TODAY!!! ARGH!!!
daffydoug
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Wow. All this new information..all good, but I need to sort through it because I'm going into information overload.

Hard for me to make a decision, now, because I know nothing about contacts from personal experience, and it is hard for me to sort truth from fiction, here.

The part about eyeball cancer kind of caught my eye..no pun intended.

Anyway, the last thing I want in life is rotten, stinky gunk dripping out of my eyeballs.
The difficult must become easy, the easy beautiful and the beautiful magical.
cheekychap
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Quote:
On 2010-08-03 11:24, daffydoug wrote:
Wow. All this new information..all good, but I need to sort through it because I'm going into information overload.

Hard for me to make a decision, now, because I know nothing about contacts from personal experience, and it is hard for me to sort truth from fiction, here.

The part about eyeball cancer kind of caught my eye..no pun intended.

Anyway, the last thing I want in life is rotten, stinky gunk dripping out of my eyeballs.


I don't think its as bad as I maybe made it, but I'm just curious if the lenses are a one size that will fit all users, or would there be problem in sizes
Lou Cirulli
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Quote:
On 2010-08-03 11:24, daffydoug wrote:
Wow. All this new information..all good, but I need to sort through it because I'm going into information overload.

Hard for me to make a decision, now, because I know nothing about contacts from personal experience, and it is hard for me to sort truth from fiction, here.

The part about eyeball cancer kind of caught my eye..no pun intended.

Anyway, the last thing I want in life is rotten, stinky gunk dripping out of my eyeballs.


I agree with you my friend! I was milliseconds away from putting my order in until I read about the eye problems! Maybe I'll wait till everyone else gets it and see what they have to say!
Xiqual
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I am so moving to Louisiana!
Anyway, enough of the doom and gloom nay sayers. Cheekychap, thanks for your wet blanket demo. I think we have had enough FDA copy and paste to last us all a few decades.

I can't wait for this to arrive! Berk, you are a mad genius!
James


Quote:
On 2010-08-03 09:46, paisa23 wrote:
There are gas stations in Louisiana that sell color contacts right next to the Bubble Gum.
Still with the Chinese circus Smile
paisa23
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LOL, I was floored when I saw that... But Doug no here is the thing; Contacts take a while of getting use too. Especially the putting in part. I remember when I got my first set, I couldn't GET THEM IN TO SAVE MY LIFE!!! Even after a while of not wearing them it can be a bit of a pain. When you have them ON for a while that can be irritating too. In a Smokey room for hours your eyes can get Dry, I always have drops with me. My contacts have never been prescription or sized by a doctor. I might have too if I was getting Full contacts where they cover the entire eyeball like black sclera’s or others like that. Berk says he has experimented with Hundreds of them to find what he wanted this effect to look like. I think BioKinesis is going to be learning experiences for those who ALREADY have experimented with Contacts so for those that have never worn them, understand that it will take some time on top of getting use to wearing contacts. That’s why I have been wearing my regular color and red contacts
NOW so I can get use to wearing them before Biokinesis releases. I have a bud that liked my red ones bought a pair and at my place took him over an hour to put ONE in. and hour of Irritated Red teary eyed frustrating yelling that he couldn't get it in. (THATS WHAT SHE SAID) but he finally did and the second one only took him 20 minutes. You learn to keep your eye open, or at least find a way to keep them open, my fiancé wears prescription contacts and she pops them in and out One handed and everything. I cannot, I need to have my right hand over my head to hold my upper eye lid open and my left hand with contact on pointer finger and middle finger pulling down on my lower eye lid in order to put mine it. My eye flinches too much, I also need to look directly at the contact as it’s going in while others can look away to place them... Everyone has their own tricky way of getting them in. In my experience with Contacts your fine as long as you take care of them AND THE ONE COMPLETE NO NO NO NO MATTER HOW BAD THEY BEG OR PAY YOU, DO NOT SHARE THEM, EVER!!!!But other than that friend, me personally I don't think there is anything else to worry about. But that's just me.
Marc Spelmann
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IF you intend on attempting this effect an understanding of contact lenses is paramount. We actually advise on the DVD that if you are totally new to contact lenses get an eye check, then purchase a pack of daily disposable lenses or costume lenses. Practice putting them in, cleaning them, handling them etc. BUT do NOT try the effect as they are not designed for the effect.

The gimmicks are designed in a slightly different way and have a unique quality to them.

MS
It's not goodbye, just see you later...
Lou Cirulli
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Marc. What will the system be on ordering refills?
paisa23
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Lou I don't think they have even come to that bridge yet, First I'm guessing they need to see how good the original does in sales since I beleave they would have to order in a large mass in order to get productions of them..
Lou Cirulli
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That's a valid statement! Thanks brother!!
daffydoug
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I appreciate all the advice everyone has given, here. Still a mountain, for me to wade through, though, before I make a buying decision!

I don't want to decide hastily, without being informed, but with all the help everyone has offered, I think I should be able to come a personal, conclusion soon.

I mean, it's my eyes, my magic career, and I'm a responsible adult, no?

Don't answer that, guys!
The difficult must become easy, the easy beautiful and the beautiful magical.
Philipp K
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Just one big question for me remains (I have read through all this in 5min so I might have overlooked an answer to it, please pardon me if that is the case)

Is there any way the gimmicks might get stuck?
I mean in a way that I can't remove them myself anymore?

Thanks,
Phil
Doc Brown : If you put your mind to it , you can accomplish anything .
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