Nestle eyecare unit Alcon rejects claims of faulty machines Sunday, August 29 16:37:33AFX ZURICH (AFX) - Nestle AG's majority owned eyecare unit Alcon Inc said that allegations regarding faults with its LADARVision 4000 laser eye surgery machine are "false and inaccurate".
Alcon's statement was in response to an article in the Saturday edition of UK daily The Times about two lawsuits filed in the US claiming that some of these machines are faulty, leading to damage to eyesight.
"This article is based on the invalid contentions of parties who are attempting to avoid multi-million dollar debt owed to Alcon by raising claims that are completely unsupported by scientific or legitimate evidence," the company said. "The LADARVision system is safe and effective."
The Times said it has seen leaked data which "appear to support the contention that some machines operated erratically between 2000 and 2002. It suggests that in 2002 more than a third of patients had to be re-treated at more than a dozen surgeries."
The paper also said it has had information from more than 20 doctors in Canada and the US who say that they have had problems with LADARVision devices.
The article also said a machine used in a Boots Group PLC London eye surgery clinic was one of a problem batch of lasers identified by Alcon in 2001 and was subject to a US Food & Drug Administration (FDA) enforcement report.
The problem was modified on site in 2001, the paper said.
Alcon rejected the allegations in a statement issued on Saturday.
Claims made in the article regarding retreatment rates with LADARVision are "false", it said.
"They are based on a fundamental mischaracterization and incorrect analysis of an internal Alcon financial document that have lead to the article's invalid conclusion. The document referenced does not provide information that can be used to accurately calculate retreatment rates," it said.
Moreover, "field action" taken on machines in 2001 was in order to "prevent a potential malfunction, and ensure the continued safety of the laser," Alcon said.
Alcon notified the FDA of this field action and the FDA reviewed the field action and deemed it closed, Alcon said.
scs/ak
For more information and to contact AFX: www.afxnews.com and www.afxpress.com
Reply With Quote
Bookmarks