Bausch & Lomb Permanently Removes ReNu With MoistureLoc Product Worldwide
According to U.S. drug regulator FDA, contact lens maker Bausch & Lomb has finally decided to permanently withdraw its lens solution "ReNu with MoistureLoc" from global market after more evidence linked it with Fusarium infection in eye.
Bausch & Lomb has proposed that unique characteristics of the formulation of the ReNu with MoistureLoc product in certain unusual circumstances can increase the risk of Fusarium infection.
Based on this scientific and epidemiological data suggesting that ReNu with MoistureLoc may increase susceptibility to Fusarium.
As part of the joint Center for Disease Control & Prevention (CDC) and FDA investigation, field officers have been inspecting the Bausch & Lomb plant and facilities in Greenville , SC since March 22, 2006 . While the plant inspection is being finalized, there is still some additional testing to be completed. The agency plans to issue observations from the inspections imminently.
Since June 2005, more than 120 people across the United States were infected with Fusarium keratitis. Most confirmed cases have been associated with the Bausch & Lomb solution, FDA said.
Fusarium is a fungus typically found in plants and soil in tropical and subtropical areas. The infection can last several months without treatment, and can scar the cornea and cause blindness.
Eight patients in the U.S. have reportedly undergone cornea transplant surgery after the fungal eye infection. Several patients are suing the company.
The fungal eye infection outbreak was also reported in Singapore, Malaysia and Hong Kong from 2005 to February of this year. Health officials discovered that almost 40 Asian cases were linked to contact lens users.
Source: FDA
Filed under Contact Lens, Eye Treatment
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