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New Visian ICL Inspection Raises FDA Concerns

FDA issues warning letter after inspection of clinical trials for approval of new toric Visian ICL and review of adverse effects of current ICL.

Visian ICL

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)  often 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.

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