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FDA Not Ready To Order Recall Of Bausch & Lomb ReNu

May 7, 2006

• Another, Bigger "Complete MoisturePlus" Recall • "Complete MoisturePlus" Contact-Lens Solution Recalled • Texas Sues Contact Lens Dispensers • Studies Find Laser Surgery Safer than Contacts • CDC Confirms MoistureLoc-Eye Infection Link • Bausch & Lomb Recalls Contact Lens Solution • FDA Not Ready To Order Recall Of Bausch & Lomb ReNu • Bausch & Lomb Facing Multiple Lawsuits • Analyst Sees More Bausch & Lomb Recalls Ahead • Bausch & Lomb "Withdraws" ReNu Contact Lens Solution • Wal-Mart, Walgreens Stop Selling Bausch & Lomb ReNu • Serious Eye Infections Linked to Soft Contacts --- • Consumer complaints about AMO Complete MoisturePlus • Consumer complaints about Bausch & Lomb ReNu • Vision Care

Though suspicion continues to mount that Bausch & Lomb's ReNu products are behind an outbreak of a rare but serious eye infection, the FDA says it has not concluded there is enough evidence to initiate a recall.

The agency says patients with confirmed cases of Fusarium keratitis have reported using various contact lens cleaning solutions including various types of ReNu products and generics.

"We continue to confirm reported cases associated with products other than ReNu with MoistureLoc," the FDA said in a statement.

"Our interest in the MoistureLoc product is based on the disproportionate number of case of Fusarium keratitis associated with ReNu with Moisture Loc compared to the overall product market share. The trends of reported cases involving various contact lens solutions other than MoistureLoc have remained consistent throughout our investigation," FDA said.

As of May 5, the Centers for Disease Control said it had received reports of 102 confirmed cases, 12 possible cases and 81 cases still under investigation from 31 U.S. states and territories.

CDC said not all data are available for all confirmed cases. However, as of May 2, 2006, of the 58 confirmed cases for which CDC has complete data:

• 56 wear contact lenses;
• 32 reported using any B&L ReNu with MoistureLoc;
• 15 reported using any B&L ReNu MultiPlus;
• 7 reported using any unspecified B&L ReNu;
• 3 reported using any AMO product;
• 3 reported using any Alcon product

Some cases reported using more than one type of solution and therefore the solution categories are not mutually exclusive.

Last week a Wall Street analyst downgraded Bausch & Lomb stock, saying it was likely more of the company's product would be recalled. So far, the FDA has not taken that step.

"FDA continues to work with the CDC to investigate the Fusarium keratitis infections and will determine whether or not further action needs to be taken" the agency said. "While the investigation is ongoing, FDA will continue to update the public health notice and advice to consumers as needed."

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