FDA: Bausch and Lomb Did Not Take Proper Action on ReNu

July 4, 2007, 9:15AM. By Anne Borden

Washington, DCA Food and Drug Administration (FDA) report asserts that Bausch & Lomb did not properly notify the FDA about 35 cases of serious fungal eye infections caused by ReNu with MoistureLoc that were reported in 2006, prior to the company's recall of the contact lens solution.

The FDA also states that Bausch & Lomb did not follow proper procedure at the Greenville, S.C. manufacturing plant at the center of the groundswell of lawsuits from victims claiming serious and painful eye infections.

The FDA and the Center for Disease Control (CDC) have received hundreds of reports of suspected fungal keratitis related to ReNu with MoistureLoc. Severe infections can result in permanent loss of sight or a significant loss of vision. Some victims have required corneal transplants to prevent them from going blind.

Failure to Disclose
Back in November 2005, Hong Kong health officials alerted Bausch & Lomb about an increase in hospital admissions due to contact-lens-related fusarium keratitis. Then in February 2006, 39 more cases were reported in Singapore. In March 2006, a New Jersey ophthalmologist reported three cases to the CDC. By March 18, 2006, eight victims had required corneal transplants and an FDA investigation had commenced. Since then, hundreds of cases have been reported to the CDC.

According to the FDA, the 35 cases initially found in February 2006 had not been properly reported to the government by Bausch and Lomb. The FDA stated that:

"A report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device may have caused or contributed to a death or serious injury".

Indeed, it wasn't until May 15, 2006 that Bausch & Lomb permanently recalled Greenville-made ReNu with MoistureLoc from the worldwide market. For some consumers, it was too late.

Plant Inspection
The FDA also released the findings of an inspection team which faulted Bausch & Lomb in 20 procedural areas, stating that Bausch & Lomb failed to:

• Follow procedures to prevent contamination of equipment and products;



• Properly define and document procedures for controlling environmental conditions at the plant;



• Implement procedures to control storage of product in storage areas and stock rooms;



• Conduct quality control audits; and



• Implement procedures to prevent problems during the handling of the product.

Eroding the Public Trust
"Unfortunately, some companies try to sweep these types of complaints under the carpet," says one business ethics consultant. "But that is never a good idea. Not only does it hurt consumers, it also erodes the public's trust.

"In this case -- an eye-care product -- it may be impossible [for a company] to regain the public's trust."

Bausch & Lomb now faces at least 400 consumer lawsuits related to the product by contact lens-wearers claiming severe infections and, in some cases, blindness.

If you have experienced eye problems that may be related to ReNu with MoistureLoc, it is crucial that you seek the care of an ophthalmologist to ensure the health of your eyes. You may also wish to speak to a lawyer about your legal rights.