After evidence showed a link between Fusarium Keratitis risk, a fungal eye infection, and contact lens cleaner, ReNu with MoistureLoc, Bausch & Lomb is removing it from the market. The eye infection can lead to serious vision loss and even blindness.
122 cases of Fusarium Keratitis have been reported in the USA, most of which are linked to usage of ReNu with MoistureLoc lense cleaner, says the FDA. Over two million Americans regularly use ReNu with MoistureLoc. The FDA does not think ReNu MultiPlus and ReNu Multi-Purpose are linked to eye infections. So far, eight patients have had to have corneal transplants.
Dr. Daniel Schultz, FDA, said that a baseline rate is always associated with some other products, but infection was clearly linked to a much higher rate of fungal eye infections among MoistureLoc users.
In a public statement, Ronald Zarella, Bausch and Lomb’s CEO, said the company is removing ReNu MoistureLoc from the market because customer safety is the their number one priority.
Experts are still unsure why the product is causing the eye infections. It could be something with the way the product is being used, stored, produced – or a combination of these factors and perhaps some others.
An ongoing CDC and FDA inspection of the Bausch and Lomb plant in Greenville, South Carolina, USA, may offer some clues. Perhaps there are issues related to Good Manufacturing Practices – whether they are connected to outbreaks of fungal eye infection is doubtful, said Dr. Schultz.
Other parts of the world, namely Hong Kong and Singapore, have reported higher than normal cases of Fusarium Keratitis among users of Bausch and Lombs contact lense cleaners. In February, 2006, the company suspended sales of ReNu in those two countries after reports of eye infections surfaced in November 2005.
Written by: Christian Nordqvist
Editor: Medical News Today