The Magic Caf
Username:
Password:
[ Lost Password ]
  [ Forgot Username ]
The Magic Cafe Forum Index Latest and Greatest? Alakazam presents "Biokinesis" by Berk Eratay (0 Likes) Printer Friendly Version

 Go to page [Previous]  1~2~3..12~13~14~15~16..20~21~22 [Next]
Navy
View Profile
New user
59 Posts

Profile of Navy
I basically wrote MJM and if they can't deliver and are only sending instructions at a lower price and have to get them on the outside, I'll request a full refund. Perhaps they can arrange to mail them outside the USA which is the only way out at this time...
paisa23
View Profile
Inner circle
7293 Posts

Profile of paisa23
WHoa... that's not good . Hocus-pocus what say you?
supermonster
View Profile
New user
16 Posts

Profile of supermonster
Penguin magic said to me yesterday evening that they have it already and it's big seller?? Wft? Why there are no reviews then?
iluzjonista
View Profile
Regular user
185 Posts

Profile of iluzjonista
Is there any european dealer who sell it at the moment?
LeeAlex2002
View Profile
Inner circle
1006 Posts

Profile of LeeAlex2002
Quote:
On 2010-09-02 04:07, supermonster wrote:
Penguin magic said to me yesterday evening that they have it already and it's big seller?? Wft? Why there are no reviews then?


This has not arrived at the wholesalers yet - how can Penguin stock this?
Yours Magically,
Lee Alex

http://www.magic2wear.com
supermonster
View Profile
New user
16 Posts

Profile of supermonster
Quote:
On 2010-09-02 06:26, LeeAlex2002 wrote:
Quote:
On 2010-09-02 04:07, supermonster wrote:
Penguin magic said to me yesterday evening that they have it already and it's big seller?? Wft? Why there are no reviews then?

This has not arrived at the wholesalers yet - how can Penguin stock this?

I don't know, I asked beacuse it says ''This item is expected to arrive on August 30th, 2010'' and it's 2nd september in Finland... I used penguin chat and someone told me they have it, but they have not updated it on site. And they told me it has been very big seller. I don't know then...

Quote:
On 2010-09-02 06:04, iluzjonista wrote:
Is there any european dealer who sell it at the moment?

I asked from Finnish dealer ''www.markkupurho.fi'' and they said that they will probabaly sell it, when they get it (or if they get it).
I wear crazy lenses and I have never needed prescription, so I think it's possible to sell them here.
Navy
View Profile
New user
59 Posts

Profile of Navy
My update from MJM as of five minutes ago.

"Jerry - No worries. I have no problem issuing you a full refund to your PayPal account (or a store credit towards something else if you prefer). I am just waiting on a FINAL answer from the supplier next week. I am about 90% sure that we will not be able to supply the lenses, mainly because the company we purchase these from is probably not going to ship them to any dealers that way. Therefore, it's like tying our hands before we even have a chance to decide if we want to send lenses or not, because it appears as though we won't be given any lenses due to the laws in the USA:

I requested a full refund, which is not a problem on their end. Do not want a store credit.

Posted: Sep 2, 2010 4:33pm
Supermonster....I just got off the phone with six magic dealers and also the distributor. All told me as of no this is not going to be distributed. I do not know if Penguin has something special worked out, or if they are working with hope that it will go through. Everyone has told me including the distributor that it is not going to happen at this time...

Posted: Sep 2, 2010 4:36pm
Hocus Pocus is not offering them right now unless they are allowed to be sold in the US.

Posted: Sep 2, 2010 5:05pm
Just got my refund and I am done with this.
Chris Oberle
View Profile
Elite user
California
455 Posts

Profile of Chris Oberle
Wow! Glad I didn't preorder
paisa23
View Profile
Inner circle
7293 Posts

Profile of paisa23
WAit, WHAT? ima have to contact HP about this. Marc what is the news brother?
Navy
View Profile
New user
59 Posts

Profile of Navy
Hiphopperco....I do not think it is an issue of having problems with a pre-order. I did and had no problem getting my money returned to my paypal account. What I am wondering is, if you buy it from another country can it be shipped here with all the parts. One of MJM's ideas was to ship it from another country. Out of all the shops I spoke to today, they cannot sell it here (USA).....
Lou Cirulli
View Profile
Special user
587 Posts

Profile of Lou Cirulli
This is an email I wrote to Acar over at Penguin last night!

Hi Acar,

Lou Cirulli from Buffalo, NY here. Had a quick question for you! I understand
there has been a little issue with Biokinesis! I preordered from you guys and
was just wondering if you knew what the 411 was on this item?! Will you guys
still be shipping these out? Thanks Acar and hope you are well.

Lou Cirulli

Just got a response back 40 minutes ago!

Hi Lou, sorry for the bad news, but yeah there was a slight delay. The product needs to be repackaged to comply with the laws here in the states. So we're working with the manufacturer on it as quickly as possible. I hope to have an update for you on that really soon.
supermonster
View Profile
New user
16 Posts

Profile of supermonster
Ok, I understand they can't sell it in USA but what about Europe?
Kakuna
View Profile
New user
38 Posts

Profile of Kakuna
I don't think there would be a problem selling in Europe, I heard about the US regulations about this some years ago. The effect is something I would use on a TV special for example, or in a halloween gig. It's def amazing.

K
Navy
View Profile
New user
59 Posts

Profile of Navy
Lou, I talked about ten dealers yesterday and the distributor and the bottom line is, they are not allowed to sell the product in the United States. The dealers within the US can ship to other countries. I do not know what Penguin has up their sleeve. If they figure a way to sell it in the US then they will be the only one.
Chris Oberle
View Profile
Elite user
California
455 Posts

Profile of Chris Oberle
So whats the news guys this was supposed to be released beginning of late august early september
Xiqual
View Profile
Inner circle
Upper left quadrant
4932 Posts

Profile of Xiqual
Hocus Pocus offered me a cash refund for $77 or a $100 store credit. I took the credit.
Hocus Pocus is a class act.
James
Still with the Chinese circus Smile
InfinityDream
View Profile
Regular user
196 Posts

Profile of InfinityDream
One word: WOW!!!!

This is effect is perfect to kill my mor-in-law...

:D

-Antonio
slyhand
View Profile
Inner circle
Good ole Virginia
1888 Posts

Profile of slyhand
I am not getting a response back from SM Productionz, which is where I purchased mine.

I have never pre-ordered anything before except recently. Both times things have gone wrong. No more pre-orders for me, ever.
I am getting so tired of slitting the throats of people who say that I am a violent psychopath.

Alec
cheekychap
View Profile
Regular user
141 Posts

Profile of cheekychap
I posted about the USA law ages ago in this post, and said there would be problem
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!

Quote:
On 2010-08-03 09:05, cheekychap wrote:
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 FDAs 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 FDAs 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 FDAs 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 FDAs Import Alert #89-08, Detention without Physical Examination of Devices without Approved PMAs or IDEs 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 FDAs web site http://www.fda.gov/NewsEvents/Newsroom/ PressAnnouncements/2004/ucm108366.htm.
Xiqual
View Profile
Inner circle
Upper left quadrant
4932 Posts

Profile of Xiqual
Uhhh... let's not.
This is a dead issue. Get a refund.
James
ps
Cheeky, I am truly sorry you could not pass the bar exam. Try again next year.

Quote:
On 2010-09-04 08:37, cheekychap wrote:

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

[/quote]
Still with the Chinese circus Smile
The Magic Cafe Forum Index Latest and Greatest? Alakazam presents "Biokinesis" by Berk Eratay (0 Likes)
 Go to page [Previous]  1~2~3..12~13~14~15~16..20~21~22 [Next]
[ Top of Page ]
All content & postings Copyright © 2001-2020 Steve Brooks. All Rights Reserved.
This page was created in 0.29 seconds requiring 5 database queries.
The views and comments expressed on The Magic Café
are not necessarily those of The Magic Café, Steve Brooks, or Steve Brooks Magic.
> Privacy Statement <

ROTFL Billions and billions served! ROTFL