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Copyright 2018 - Laserworld Group

Statement of Martin Werner on behalf of the Laserworld Group concerning the Safety Communication issued by the FDA on Nov 7, 2017:

 

Nov 10, 2017

Dear Customers,

Dear Laserists,

And to whom it may concern:

 

I like to give you a first response to the notification released by the FDA on Nov 7, 2017.

The FDA and Laserworld have a long mutual history and I can personally assure you that no matter how much some people believe to know about it, it is just a small portion of the truth.

It’s not new that the administration published selective information with the intent to explicitly harm Laserworld in the past years while we were legally bound to stay silent not to negatively impact on our efforts in cooperating with the agency.

In a world where it became common practice to rule a country by Twitter I understand this notification is the answer to my response sent to the FDA on Aug 13, 2017.

It took only 3 months – pretty fast this time.

I might be old fashioned to a certain extent as I prefer to solve disputes face to face, but I’m learning quickly:

 

You can view my email sent to the FDA in August here (click)


For all those who already rendered their judgment or blamed Laserworld for not responding I can only say one thing: I haven’t heard from the FDA since August 2017, nor did ILDA inform me upfront of their statement or asked for clarification. I won’t let you wait for months to get the other side of the story, but given the complexity of this matter I hope 3 days for this first statement is still an acceptable timeframe.

I’ve given it much thought how to respond best to such a complex matter and without the exposure to more speculations and tons of further questions.

The simple answer is:

 

I’m going to publish everything.

All documents and communication between FDA and Laserworld. This will include any product reports and other so called confidential documents. I’ll not tell my side of the story - make up your mind by yourself!

 

Why?

Honestly, I can already say at that stage of the year that we’ll luckily manage to write the by far most successful year in our company history this 2017. The Laserworld Group is a leading manufacturer of show laser light systems worldwide and still keeps on growing. I’m very thankful having the best team around me and I thank all partners and clients for their continuous trust in us.

Within this same year, we’ve ultimately closed our US endeavor which enables me after so many years to finally share my experience with the rest of you. Laserworld USA has nothing to lose or to win anymore. No matter the impact my engagement in this matter may have or changes that may happen in the FDA administration in the course of the years – after burning more than $2M investment into being a CDRH compliant manufacturer in the USA, we won’t ever return.

Now, I think it is important for the whole laser light show industry in the USA to face the facts and to consider a couple of serious issues. It’s a crazy world sometimes and I don’t want to end up seeing people getting shot with guns in the US each week while laser light show displays maybe disappear in the future completely? Excuse my words, this shall be no criticism, but I’m speaking out loud what many in Europe think.

FDA’s Summary of Problem and Scope contains fragmentary, false information purposely supporting a wrong assessment of the public – and by far beyond their judicial area of authority.

Yes, I’ve learned there are “variances” and “variances”. Some are better than the others although the letters from CDRH look the same. In correspondence with the ILDA Statement, it is correct that Laserworld did hold its first variance and without any room for argumentation – until at least August 31, 2015. I never got an answer why our clients in return got informed for the same period that we would not be a variance holder same as the latest publication shall make people believe. The same applies for an automatic extension of the variance based on filing an annual report – a so far common practice, but some can file too late and it’s all fine, and some file in time and receiving no extension?! To just name a few examples – interesting files to follow!

I’ll prove that FDA’s technical evaluation of laser light show products changed completely in the course of the last 3 years and no matter how weird the new requirements, Laserworld adapted its products and corresponding product reports at all time. Any corrective actions granted are completed on our end, but we’re still waiting for the very first one to be closed from the FDA. Honestly, we’ve gone for tremendous efforts I doubt anyone else did in this extent to strategically eliminate any future risk exposure completely. This included double and three times interlock systems per laser device, two key switches and much more. Did it help? No!

The lack of responsiveness by the agency is a matter of its own. The only time I’ve seen progress was when first legal steps were initiated to enforce action on their end. My biggest mistake in this whole journey was probably to trust the promises made at that time which led me to withdraw our appeal.

The FDA made substantial changes in procedures, specifically in regards to the requirements how show variances are granted. Latest with the release of ILDA’s communications after last year’s conference everyone should know what I’m talking about, however the real extent I’ll make visible with the upcoming releases of statements accomplished with documentation since the agency doesn’t stop to apply the same for previous periods as well! This can and most probably will have serious effect to the absolute majority of all holders of a Show Variance on the US market.

The impact of all before mentioned points is nowadays visible in selective enforcements – refer to Laserworld as the best but by far not only example and I’m pretty sure further actions may follow soon. Without a doubt, the FDA can shut down any of your companies instantly if they just wanted to.

Who profits? Certain market participants can sell a hundred Thousands of lasers without respecting any regulations or even filing any reports with the FDA, same as other known laser companies can perform laser light shows since years although dozens of complaints were filed with the administration but without the slightest effect.

Laserworld strives to create the safest lasers possible. In order to guarantee all global and local regulations are fulfilled, we have hired multiple third party consultants worldwide that externally certify each single product. The same applied for the USA.

I can personally assure everyone outside the USA that none of the matters raised by the FDA are of any relevance for you at all. For the avoidance of doubt I’m happy to disclose safety aspects related company data of your specific product you purchased from us or give contact information to other users in the world that can share their experiences with you.

For those being irritated by the information released by the agency or seek fast guidance on specific questions, please don’t hesitate to reach out to me personally (This email address is being protected from spambots. You need JavaScript enabled to view it.) any time!

I’ll keep you up to date about the release progress.

 

Kind regards,

 

Martin Werner
CEO

 

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