Where's Tetraflex IOLs & US FDA Testing?

[Koodam]

Where's Tetraflex IOLs & US FDA testing?   Been browsing this site & learned quite a bit about IOL replacements for Cataract Surgery, but haven't been able to find much here about Tetraflex IOLs & US FDA testing.

Nov 19, 2006 Tony12 posted about positive experience with bilateral Tetraflex IOLs done for him(her?) in the UK.   Dec 08, 2007 Dr. Hagan posted that, in the US, the Tetraflex IOL is still in clinical trials with the FDA.   And Dr. Hagan's post let us in on the results from a study of Tetraflex performance done by Dr. Donald Sanders, MD, PhD, in the United Kingdom.

Tetraflex accommodating IOLs seem similar to the Bausch & Lomb Crystalens IOLs except that they work, without a hinge, more like the natural lens.  I understand people in other countries don't have to follow US FDA rules.  But, FDA approval is recognized as an indicator of good quality; so, why are Europeans, Asians, Canadians, & Mexicans getting Tetraflex instead of Crystalens?

Is this some issue of national pride or economics or do these foreigners think they can make a better product than US?   What's up?

Koodam

[cdn_glenn]

http://www.lenstec.com/lenstec/tf_trialdocs.html

[Koodam]

Cdn Glenn, thanks so much for your very short and very helpful one line reply: "http://www.lenstec.com/lenstec/tf_trialdocs.html".

From the URL you provided I went to the Lenstec, St. Petersburg, FL USA, index page: http://www.lenstec.com/index.html; looked at their U.S. Residents page, & then went back and looked at their "All Other Countries" pages: http://www.lenstec.com/lenstec/menu_row.html.

Very informative- I feel like I learned a lot.  Thank you.

I expect Dr. Feldman, MD, MS, is a good doctor, but still I got more from your answer.  I expect it wasn't news to me that "Different countries have different requirements for regulating the use of new devices or drugs."

Thanks again for your reply.   I would greatly appreciate any thoughts from anyone that’s had personal experience with the Tetraflex IOL.

Koodam

[cdn_glenn]

You're welcome Koodam!

I have bilateral Tecnis multifocal IOLs.  I did want accommodative IOLs.  My only choice at the time was the German-made Akkommodative 1CU

http://www.humanoptics.com/go/humanoptics/en/home/produkte/aspira/1cu.xhtml

My surgeon advised they would not give good near vision.  I might be able to focus near for about three minutes, then need to switch to reading glasses.

Good luck with the trial if you do go ahead with it!

Glenn

P.S. I did try to reply to your PM, but I think you've inadvertently blocked me.

[Sandy Feldman, MD, MS]

Dear Koodam,

Different countries have different requirements for regulating the use of new devices or drugs.

Dr. Feldman

Sandy T. Feldman, M.D., M.S.
ClearView Eye and Laser Medical Center
San Diego, California