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 was not responding to my inquiries.

I never received a reply from the FDA, so I assumed it went
into the dust bin. Maybe they actually read it :-).

...Ken


--- In piolusers@yahoogroups.com, mdwyer@... wrote:
>
> > 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. :(
>