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Contact Lens Solution Infection Complaints Not Reported to FDA

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Despite having received 9  reports of a parasitic infection occurring in users of  Complete MoisturePlus contact lens solution in the year before the defective solution was recalled, Advanced Medical Optics (AMO) did not properly  report the complaints to the Food & Drug Administration (FDA), according to documents obtained by the Associated Press.

The documents, revealed in the course of Complete MoisturePlus lawsuits resulted from, a previously undisclosed inspection by the 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.

Medical manufacturers are supposed to report product complaints tied to serious injury within 30 days of the end of each quarter. 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.

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.

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