A Medical Device Daily
Bausch & Lomb (B&L; Rochester, New York), currently battling charges that its lens cleaning solution products may be related to the occurrence of severe eye infections among contact lens users, is also facing increased accounting problems internationally.
Reports continue to indicate that the investigation into the accounts of the company's foreign units has been widened from Korea to India, Japan, Thailand and Brazil.
These investigations are likely to make more difficult the reports of its 2005 financials, already delayed. The irregularities will also hit its 2005 results, which have been delayed.
On Monday the company said a probe of its Brazil subsidiary is complete and the probe of its Korea subsidiary is nearly complete. But other investigations appear to be ongoing.
The company said in a filing that results of the probe into its operations in Brazil would reduce the company's previously reported net income for the first and second quarters of 2005 by $600,000 and will reduce the previously reported net income for 2000-2004 by $19 million.
The probe of its Korean business will result in revenue recognition adjustments for vision care sales in Korea from 2002 to 2005. The company currently estimates the unaudited impact of an accounting change would be to reduce previously reported net sales for 1Q05 and 2Q05 by about $1.2 million and reduce the previously reported net sales for the period 2002-2004 by a total of about $7.2 million.
Meanwhile, the Centers for Disease Control and Prevention (CDC; Atlanta) on Tuesday said it has confirmed additional U.S. cases of a rare eye infection called Fusarium keratitis, with an unusually high percentage of the cases being reported by users of B&L contact lens solution products.
The agency said in a statement that as of May 9, it had confirmed 106 cases of the infection, which can lead to blindness if not properly treated.
Of 98 confirmed cases for which the CDC said it has “complete data,” 66% said they used B&L's ReNu with MoistureLoc contact lens solution, while another 21% said they used a ReNu MultiPlus solution.
About 7% of the cases used products made by Alcon (Fort Worth, Texas).
In its most recent statement on the eye infections, the CDC said that it is still too early in the investigation to link the infections to a particular product or solution.
However, it added that during the course of its investigation, “the proportion of patients who reported using Bausch & Lomb's ReNu with MoistureLoc has remained relatively consistent, at around 50% to 60% of confirmed cases.”
The agency said that recent publicity about the infections and the potential link to lens cleaning solutions may have also contributed to the rise of reported cases, since the infection is not one that is normally required to be reported by health professionals.
“Thus, it is possible that some of the cases currently being investigated represent infection which might normally occur and, as a result, are not related to the outbreak,” the CDC said.
While B&L has withdrawn from the market its ReNu with MoistureLoc product, its ReNu MultiPlus lens cleaning solution remains on store shelves.
Richardson, Patrick, Westbrook & Brickman (Charleston, South Carolina) this week said that it is “spearheading” the filing of suits against B&L and that it “anticipates filing more in the coming weeks and months.”
Praxis moves to bigger offices
Praxis (Brentwood, Tennessee), a company specializing in centralized patient recruitment for clinical research studies, said that it has relocated to larger offices in Brentwood. The expansion comes as part of the company's ongoing growth in the field of pharma/biotech patient recruitment services.
President David Fox said, “The new location allows us to comfortably place all of our staff, and leaves additional room for future development.”