ReNu Lens Solution
A product with a unique formula and a specific use whose maker kept it on the market while user reports of injury mounted--it's an old story. But Bausch & Lomb didn't learn the lesson, according to plaintiff lawyers representing people who suffered eye damage after using the company's ReNu with MoistureLoc to clean their contact lenses.
Introduced in late 2004, the multipurpose solution for cleaning, rinsing, disinfecting, and storing soft contact lenses made about $100 million in sales in 2005. But reports of Fusarium keratitis--a severe fungal infection of the cornea potentially leading to corneal scarring and blindness--began to circulate among users of the solution, first surfacing in July 2005 in Singapore and later in Hong Kong.
Bausch & Lomb recalled the product from Asian markets in February 2006 but did not alert U.S. users or the FDA to the problem. The FDA originally approved ReNu with MoistureLoc as a medical device under §510(k) of the Food, Drug, and Cosmetic Act.
The FDA's list of risk factors for Fusarium keratitis includes "chronic ocular surface diseases, immunodeficiency, and rarely, contact lens use." As reports of eye infections by contact lens users multiplied, the agency launched an investigation that linked a higher risk of developing Fusarium keratitis to those who used the ReNu solution compared with those who used other multipurpose contact lens solutions.
On April 10, 2006, the FDA and the Centers for Disease Control and Prevention (CDC) issued a joint press release alerting consumers and health care professionals to the risk. Bausch & Lomb voluntarily withdrew ReNu with MoistureLoc from the U.S. market three days later and issued a worldwide withdrawal on May 15.
The contact lens solution's connection with infection is still under investigation. "After an extensive investigation involving thousands of tests, millions of dollars, and collaboration with government agencies, health authorities, and independent experts, there is no evidence of product contamination, tampering, counterfeiting, or sterility failure," company Chairman and CEO Ronald Zarrella said at the recall. "That leads us to conclude that some aspect of the MoistureLoc formula may be increasing the relative risk of Fusarium infection in unusual circumstances."
If you or someone you know has been injured by ReNu Lens Solution contact our office right away. Let our experienced team of attorneys properly evaluate your case. 619.615.0767
Introduced in late 2004, the multipurpose solution for cleaning, rinsing, disinfecting, and storing soft contact lenses made about $100 million in sales in 2005. But reports of Fusarium keratitis--a severe fungal infection of the cornea potentially leading to corneal scarring and blindness--began to circulate among users of the solution, first surfacing in July 2005 in Singapore and later in Hong Kong.
Bausch & Lomb recalled the product from Asian markets in February 2006 but did not alert U.S. users or the FDA to the problem. The FDA originally approved ReNu with MoistureLoc as a medical device under §510(k) of the Food, Drug, and Cosmetic Act.
The FDA's list of risk factors for Fusarium keratitis includes "chronic ocular surface diseases, immunodeficiency, and rarely, contact lens use." As reports of eye infections by contact lens users multiplied, the agency launched an investigation that linked a higher risk of developing Fusarium keratitis to those who used the ReNu solution compared with those who used other multipurpose contact lens solutions.
On April 10, 2006, the FDA and the Centers for Disease Control and Prevention (CDC) issued a joint press release alerting consumers and health care professionals to the risk. Bausch & Lomb voluntarily withdrew ReNu with MoistureLoc from the U.S. market three days later and issued a worldwide withdrawal on May 15.
The contact lens solution's connection with infection is still under investigation. "After an extensive investigation involving thousands of tests, millions of dollars, and collaboration with government agencies, health authorities, and independent experts, there is no evidence of product contamination, tampering, counterfeiting, or sterility failure," company Chairman and CEO Ronald Zarrella said at the recall. "That leads us to conclude that some aspect of the MoistureLoc formula may be increasing the relative risk of Fusarium infection in unusual circumstances."
If you or someone you know has been injured by ReNu Lens Solution contact our office right away. Let our experienced team of attorneys properly evaluate your case. 619.615.0767