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Bausch & Lomb Recalls Contact Lens Solution

By Mark Huffman
ConsumerAffairs.com

May 15, 2006

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Weeks after an outbreak of serious eye infection focused attention on Bausch & Lomb’s ReNu with MoistureLoc, the Food and Drug Administration has announced the company is recalling the contact lens solution.

The FDA says a team from Bausch & Lomb met with officials last week to share information resulting from the company's internal investigation into cases of Fusarium keratitis associated with ReNu with MoistureLoc.

Bausch & Lomb has concluded that unique characteristics of the formulation of the ReNu with MoistureLoc product in certain unusual circumstances can increase the risk of Fusarium infection, the agency said.

Based on this scientific and epidemiological data suggesting that ReNu with MoistureLoc may increase susceptibility to Fusarium, Bausch & Lomb has decided to permanently remove the ReNu with MoistureLoc product worldwide. The FDA said it supports this decision.

To date, available data do not indicate a problem with ReNu MultiPlus or ReNu Multi-Purpose or generic brands of this contact lens cleaning solution.

"While FDA is still concluding its scientific evaluations and expects additional information to be submitted by the sponsor, at this time we recognize that Bausch & Lomb has proposed the formulation as the potential root cause of the increased relative risk of Fusarium keratitis associated with use of the ReNu with MoistureLoc product," the FDA said in a statement.

"FDA will continue to review cultures and epidemiological data and if there is new information that adds to or changes our current understanding, we will act on it in a timely and appropriate manner."

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, the FDA said there is still some additional testing to be completed. The agency plans to issue observations from the inspections imminently.

ReNu with MoistureLoc contact lens solution, manufactured in the Greenville , SC plant, was voluntarily withdrawn from the market in the United States on April 13, 2006 . To date, a majority of the confirmed Fusarium cases have been associated with the ReNu with MoistureLoc.

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