Restor and others FDA

[Lerbea]

I think that Alcon -Restor IOL's have shown their true colors. I don't trust a thing they would say as in regards to impovements, I had Restor in June.  The fight is on to get the FDA to stop these manufacturers.  If you feel the same, I think a action must be started.  Again I'll say contact the FDA adverse reactions site and report your IOL to them. Letters need to be sent to the FDA as well as phone calls. I will find the necessary sites and numbers if anyone is interested.

I think FOOL was written across my forehead.  The same thing happened to me in regards to the TMJ implants 25 years ago. They were marketed without proper FDA approval and a 100% recall was issued.  Talk about having to pay the price. You'd think I'd know better.

What are your comments.
B.

[John C Hagan III, MD, FACS, FAAO]

-

[Lerbea]

Thanks to all who responded to my posting of this thread. I now do not feel I am the only one opposed to the Restor product.  We as patients have to be our own advocate. It surely isn't the medical profession. I've been bitten before.

Just to add that the comment my original surgeon made when I was describing my symptoms was-"Laughing he said, I saw as good as he does."  That tells you the ego in up front.

[John C Hagan III, MD, FACS, FAAO]

-

[Sharman]

Thank you for your response. My surgeon is very skilled and well-respected. He has never been asked to remove the Restor lenses before. The lenses are in perfectly - centered, no astigmatism, etc. A small haze is behind one of them and that could be removed by laser. But, once removed by laser, taking out the implant is no longer an option. And, the haz is only in one eye, not both. The sight complications are present in both eyes. I have been told the lenses could be removed, but at some considerable potential for a "tear" of some sort. I feel that I really do''t have any options available. He suggested purchasing anti-glare prescription glasses and adding trifocal to them. But, that's what I had before the expensive surgery, anyway (glare and halos were never an issue). Prior to surgery the small cataracts made things look a little less clear. I used glasses primarily for driving only. Could read well, work on computer - all in low and high light. Now, with the Restor lenses, I can't read in low light at all, can't work on the computer without glasses, and no longer can read books as a hobby. Losing driving ability at night is also a result of having the lens implanted. Just a bad, disappointing result - the Restor advertising was untrue. Great to see distance in bright light - but, that's the only correction I have. For all other uses of my eyes, Restore has handicapped me tremendously. I have no really viable options left and will file a complaint with the FDA on the fabricated claims made by the Restor company.

[John C Hagan III, MD, FACS, FAAO]

-

[JodieJ]

Please get a second (and possibly third) opinion from surgeon(s) who are very experienced with ReStor.  It's possible something potentially correctable (decentration of lenses, residual astigmatism, etc.) is affecting your vision.  If this isn't the case, then you need to know this.  It's my impression that explanting your ReStors does NOT carry a great chance of complications if the procedure is performed by a skilled and experienced surgeon.  But don't agree to the YAG laser procedure that your surgeon is suggesting--this would definitely make explanting your ReStors more difficult.

[Sharman]

My Restor lenses implants in July 2008 are a disaster. The brochure says "visual disturbances may occur." I'll tell you what occurred - at the age of 58, I can no longer drive at night due to glare and halos, I can no longer read the newspaper, work on the computer for more than ten minutes, or read the mail. I want my old cataracts back. My only choices my doctor tells me - have them removed (at a great chance of complications), or some type of laser something. Believe me, do not put Restor lenses in your eyes - you will regret it! My quality of life has been severly compromised. He also suggested going to anti-glare prescription lenses with a trifocal. That's what I used to use. But, I didn't need glasses for most reading or the computer. Now, I sit four fee from the computer screen, and have lost the hobby fo reading. I made a huge mistake believing the Restor brochure - don't make the mistake I did!

[John C Hagan III, MD, FACS, FAAO]

-

[londonbridge]

Read my post about Restor from yesterday. I reported my problems to the FDA and found 50 pages of similar problems with my model on their adverse medical device web site. I would be happy to work with others to prevent people from going through what I have to. I did not receive any "informed consent" about possible adverse reactions only the standard informed consent about the cataract surgery itself. I was prepared to deal with rings and halos not blurry vision at every distance. considering explanting the lens.

[Lerbea]

My reply would be simply "Informed consent" ha.

[John C Hagan III, MD, FACS, FAAO]

There are many happy patients with ReStor IOLs.  Informed consent for that IOL indicate that post operative problems may include need for glasses, glare and dysphotopsia. The ReStor compares well with Crystalens.

The ReZoom IOL is a different deal and unhappy patients exceed considerably those wth Crystalens or ReStor.

JCH MD