Bausch & Lomb ReNu MoistureLoc ® Contact Lens Solution
Miller & Associates
Miller & Associates is a national law firm based in Alexandria, Virginia. The attorneys handle pharmaceutical and environmental cases nationwide.
Contact Lens Solution Infection Reports Delayed
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May 18th, 2006
"Bausch & Lomb Delayed Infection Reports"
The Food and Drug Administration issued a report on Monday stating that Bausch and Lomb delayed informing regulators of reports linking its contact lens solution to cases of a rare eye infection.
The minister of health in Singapore reported 35 cases of Fusarium keratitis, a rare eye infection that could potentially lead to blindness, to the company in February. Two months later in April, Bausch still had not reported those cases to the FDA, which requires such reports within 30 days of receiving the initial information.
According to the FDA, Bausch had received additional reports in July 2005 linking its ReNu with MoistureLoc product to the eye infection. However, the company had not reported them as of May 9 this year.
Bausch initially suspended sales of the MoistureLoc solution in April 2006 after health officials at the Centers for Disease Control and Prevention began investigating reports of Fusarium in more than 100 individuals. On Monday, the company announced that it was permanently pulling the product from shelves worldwide.
So far, the CDC has confirmed 122 cases of the eye infection - the majority of these individuals claimed to have used ReNu with MoistureLoc.
The FDA is currently inspecting the plant that manufactures the product. The initial inspection found a number of “objectionable conditions” at the plant, including peeling paint and paint chips on tank agitators used in the production of the solution.
A similar condition in 2002 warranted a warning letter to the company. An inspection had discovered eye-products being filled in rooms with “paint flaking from the ceiling grids.”
The CDC and the FDA are continuing to investigate the matter.
