> 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. :(