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Reply | Forward Message #205 of 1168 |
Re: [piolusers] Intro

> Did anyone else know that STAAR Surgical was warned recently by the
> FDA? Apparently, they disregarded and didn't report some negative
> experiences of patients in the clinical trials for the latest ICL,
> and this is now going to cause their toric lens release to be
> delayed. I thought this was interesting and wondering if I was sold
> something based on incomplete information.

The Wikipedian in me requires me to find a citation for this. :)

http://www.fda.gov/foi/warning_letters/s6418c.htm

It appears to be mostly concerned about documentation improprieties, but
the third bullet point is disturbing -- there was a cataract and a retinal
detachment that were not reported. An iris bombay (which, I think is
swelling of the iris) was improperly reported.

Although my side-effects are minimal -- especially when compared against
the overwhelming positives -- it is somewhat concerning that the glare
issue is not really discussed, or even understood. The glare issure ISN'T
part of the FDA warning. Indeed, nobody here has experienced the more
severe side-effects of cataract or detachment that the warning concerns.
(Thank goodness!)

It seems like we generally all have the problem of glare (with the STAAR
Visian lens, I should note.), but the severity of it can vary drasticly.
I have no idea what causes the variability. :(





Wed Aug 1, 2007 4:44 pm

n0zap
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Message #205 of 1168 |
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Hi everyone, My name is Andy and I had the Visian ICL's implanted in early June. I'm now 2 months out from surgery and was so glad to find this group and see...
fraheracca
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Aug 1, 2007
2:52 pm

Hi Andy: Do you know your prescription? My doctor told me the stronger the correction the more the side effects. I'm scared to have PIOL, though continually...
Jean Thilmany
thilmanyj
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Aug 1, 2007
4:37 pm

Just a quick note: When you quote your diopters, make sure you note if they are for glasses, contacts, or your implanted lenses! The diopter rating appears...
mdwyer@...
n0zap
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Aug 1, 2007
5:07 pm

Hi Jean, My Visian prescription is -5.0 in each eye. I don't have as high a level of myopia as it seems many in here do. I also have astigmatism in both...
fraheracca
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Aug 2, 2007
1:50 am

... The Wikipedian in me requires me to find a citation for this. :) http://www.fda.gov/foi/warning_letters/s6418c.htm It appears to be mostly concerned about...
mdwyer@...
n0zap
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Aug 1, 2007
4:46 pm

Hi, Very interesting. I actually sent a letter to the FDA a while back, which described the problems I was having with the lens. I also mentioned that STAAR...
kensell33
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Aug 1, 2007
11:58 pm
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