MONROVIA, California, June 28, 2007, -- The US Food and
Drug Administration (FDA) issued a warning letter Wednesday to Staar
Surgical Inc., citing concerns in ongoing clinical trials for the
approval of a new version of the Visian Implantable Collamer Lens
(ICL) and lack of investigation of problems with the currently approved
version of the device. The FDA concerns will undoubtedly delay
or derail approval of the device designed to correct nearsighted
vision and astigmatism.
The Visian ICL is sometimes inaccurately referred to as an
"implantable contact lens".
The Visian ICL is a phakic intraocular lens (P-IOL)
used as an alternative to Lasik laser eye surgery. The ICL acts
as a "helper" lens implanted inside the eye behind the iris and
in front of the natural crystalline lens. The device is most appropriate
for patients with high myopia (nearsighted) vision between age 21
to 45. In late 2005 the FDA approved a version of the Visian ICL
for nearsighted vision without astigmatism correction.
An inspection by FDA officials in February and March 2007 revealed
that the company had "sponsored and initiated a clinical research
study with a significant risk" without proper FDA authorization.
The FDA inspection revealed that tests required before surgery had
not been completed and that company reports had been changed to
indicate the tests had been performed.
The FDA also found that adverse effects from implantation of
the already approved Visian ICL had not been properly investigated,
including a retinal detachment and discoloration of the patient's
iris. Additionally, the company's Medical Reviewer "discarded all
documentation regarding his evaluation of adverse events".
Revelation of these and other problems with the clinical study
will likely delay approval of the toric Visian ICL. Staar had expected
approval in 2007.