A Medical Device Daily
The Center for Disease and Control & Prevention (CDC; Atlanta) is continuing to release data on the occurrence of fusarium keratitis eye infections in the U.S., with the numbers increasing slightly from about 180 reported cases last week to 191 cases this week.
Only a minority of the cases so far have been linked to the use of contact lenses and the solutions for cleaning them, but with the large bulk still associated with lens cleaning solutions from Bausch & Lomb (Rochester, New York).
In its latest report, the CDC said that it has confirmed 86 cases of the infection, that 96 cases are "under investigation" and that nine cases are "possible."
It said that it had "confirmed" data on 58 cases, with 50 of the cases using B&L cleaners, three using cleaners from Advanced Medical Optics (Santa Ana, California) and three from Alcon (Fort Worth, Texas).
There is still no indication that either the CDC or the companies making the cleaners have identified the cause of the infections that have forced B&L to withdraw its ReNu With MoistureLoc cleaning product from store shelves.
In response to the numbers released by the CDC late Tuesday, B&L issued a statement calling the data "preliminary" and saying that the numbers need "further examination and should be placed in proper context."
The company said it continues to fully cooperate with the FDA and the CDC "in a comprehensive investigation to determine the root cause of the unusual incidence of fungal keratitis." It added that it was meeting yesterday with the CDC to review the information.
It put the CDC's analysis at 27% confirmed cases in connection with the company's ReNu MultiPlus solution, compared to the product's 40% market share.
It reported MultiPlus solution used by nearly 11 million in the U.S. and that more than 30 million consumers worldwide have used it, thus representing "an excellent record of safety and effectiveness since it was introduced in 1997."
It put the CDC's analysis at 57% share of cases reported for the company's MoistureLoc formula compared to its U.S. market share of less than 10%, a proportion resulting in the product's withdrawal while the investigation is ongoing.
Joanne Wuensch, device analyst with Harris Nesbitt (New York), issued a report projecting a continuing rise in the number of infection reports. And she predicted an "increasing chance that the company will need to pull the MultiPlus solution off the shelf."
She added: "at this stage neither agency nor B&L have been able to replicate the fungus in either a lab or at the [manufacturing] plant, making it somewhat disconcerting to us in ferreting out the root cause of the problem."
The CDC said that it would continue to report the cases of infection three times each week until the investigation is completed.
B&L's core businesses include soft and rigid gas permeable contact lenses and lens care products, and ophthalmic surgical and pharmaceutical products.