FDA sends Bausch & Lomb official warning letter after reNu with MoistureLoc investigation

In a letter dated Oct. 31, 2006 to Bausch & Lomb CEO Ronald Zarrella, the Food and Drug Administration (FDA) officially notified the company that it had found violations in its Greenville, SC production plant. The investigation was started after scientists and government officials began to make a connection between the company’s ReNu with MoistureLoc and worldwide outbreak of the fungal eye infection Fusarium keratitis. Although the violations found at the Greenville plant did not cause the outbreak, they did raise concern for the FDA.

Most of the violations were regarding record keeping practices, though other operating procedures were cited as well. With regard to ReNu with MoistureLoc and Fusarium keratitis, the FDA noted that Bausch & Lomb did not report the information they received about 35 serious cases of the infection from health officials in Singapore. By law, the company should have released this information by April 7, 2006. By suppressing this information, the company may have increased the number of people who ultimately contracted Fusarium keratitis.

The company finally removed ReNu with MoistureLoc from global shelves on May 15, 2006, though did not admit at the time that there was any clear connection between the product and the fungal eye infection. Instead, it suggested that its customers were simply not using proper cleaning methods, allowing Fusarium keratitis to develop.

"Your response [to an earlier FDA letter] states that this information did not reasonably suggest that the ReNu with MoistureLoc multi-purpose solution device caused or contributed to the Fusarium infections. FDA disagrees. This information suggested that your ReNu product may have caused or contributed to the event," read the October 31 letter.

Bausch and Lomb was given 15 days from the date of receipt of the warning letter to devise a plan to fix each of the violations cited in the 11-page letter. The company released a statement that said they had been working closely with the FDA and had already resolved two-thirds of the issues. The remaining issues would be addressed by the first quarter of 2007.

In the months after the recall, the Centers for Disease Control and Prevention (CDC) concluded that the development of the infection is most likely a combination of poor lens cleaning habits and an ineffectual product. Product liability suits citing ReNu with MoistureLoc have already been filed against Bausch & Lomb.

If you contracted Fusarium keratitis while using Bausch & Lomb’s ReNu with MoistureLoc multipurpose contact lens cleaner, contact Jim S. Adler & Associates for a free case review. You have the right to expect safety with any product available on the market. Fungal eye infections or any other injury associated with a particular product can be seen as an act of negligence on the part of the manufacturer. Call a Jim S. Adler & Associates personal injury lawyer directly at 1-800-505-1414 or fill in the free case review form on this page with the details of your case. We may be able to secure compensation to cover your medical bills, lost work, and mental anguish.

Additionally, Jim S. Adler & Associates has offices at City Place Building, 2711 North Haskell Ave., Suite 2100 LB40, Dallas, Texas 75204-2887;  San Pedro Plaza, 7330 San Pedro Ave., Suite 700, San Antonio, Texas 78216-6237; and Bank of America, 12605 East Freeway, Suite 400, Houston, Texas 77015-5619 (serving Channelview, Texas).

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