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AMO Withheld 9 Complete MoisturePlus Infection Complaints

Jun 22, 2009 | Parker Waichman LLP

Advanced Medical Optics (AMO), maker of  Complete MoisturePlus contact lens solution, had received reports of eye problems linked to the solution long before it was recalled in 2007. According to the Associated Press, documents obtained in the course of lawsuits  against AMO show that the company received 9 such reports in the year prior to the Complete MoisturePlus recall, but failed to properly report them.

As we've previously reported, AMO's Complete MoisturePlus solution was linked to dozens of Acanthamoeba keratitis infections in 2007.  Acanthamoeba keratitis is a parasitic eye infection that can  cause redness and eye pain, as well as tearing, light sensitivity, blurred vision and a feeling that something is in the eye.  A "ring-like" ulceration of  corneal tissue may also occur. Unfortunately, in most cases of Acanthamoeba keratitis, permanent vision loss occurs, and  corneal transplant surgery often is necessary to recover lost vision.

The documents obtained in the course of Complete MoisturePlus lawsuits resulted from a previously undisclosed inspection by the Food and Drug Administration (FDA), the Associated Press said.  The papers reportedly show that between February and November 2006, AMO received 9  reports of Acanthamoeba keratitis infections in Complete MoisturePlus users.  But it wasn't until the FDA performed an inspection of AMO's headquarters in June 2007 that it learned of those reports, the Associated Press said.  By that time, Complete MoisturePlus had already been recalled, and health officials had confirmed nearly 160 cases of the infection in patients across the U.S.

According to the Associated Press, AMO defended is actions by claiming it was not required to report the complaints because the labeling of Complete MoisturePlus did not claim to protect users from the parasite.

In addition to the unreported complaints, the FDA inspection turned up several other violations at AMO, the Associated Press said.  Yet the FDA did not issue AMO a warning letter - the normal step taken when violations are found - or take other action against the company.  Rather, the Associated Press, the FDA "discussed" the violations with AMO, and the company outlined a plan for fixing problems.  The plant is subject to a follow up inspection, the Associated Press said.

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