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Bausch & Lomb Pulls ReNu With Moisturloc Lens-Solution [05/17/2006]

WASHINGTON , D.C. - The U.S. Consumer Product Safety Commission, in cooperation with the firm named below, today announced a voluntary recall of the following consumer product. Consumers should stop using recalled products immediately unless otherwise instructed.

Bausch & Lomb Inc. has permanently removed from markets worldwide a contact-lens solution that has been linked by health authorities to an outbreak of rare fungal infections that can cause blindness. Bausch & Lomb has proposed that unique characteristics of the formulation of the ReNu with MoistureLoc product in certain unusual circumstances can increase the risk of Fusarium infection.

Based on this scientific and epidemiological data suggesting that ReNu with MoistureLoc may increase susceptibility to Fusarium, Bausch & Lomb decided to permanently remove the ReNu with MoistureLoc product worldwide. FDA supports this decision. To date, data available do not indicate a problem with ReNu MultiPlus or ReNu Multi-Purpose or generic brands of this contact lens cleaning solution.

While FDA is still concluding its scientific evaluations and expects additional information to be submitted by the sponsor, at this time we recognize that Bausch & Lomb has proposed the formulation as the potential root cause of the increased relative risk of Fusarium keratitis associated with use of the ReNu with MoistureLoc product. FDA will continue to review cultures and epidemiological data and if there is new information that adds to or changes our current understanding, we will act on it in a timely and appropriate manner.

The Centers for Disease Control and Prevention claims that the number of confirmed cases of Fusarium keratitis in the United States has climbed to 122, most of them contact-lens wearers who reported using Bausch & Lomb's newest cleaner, ReNu with MoistureLoc MultiPurpose Solution.

The company halted U.S. sales of MoistureLoc on April 13 after the CDC said it was investigating an unusual spike in infections in Americans using the product. The outbreak first surfaced in the Far East in the fall and infections have showed up most recently among contact-lens wearers in Europe.

The fungus is commonly found in plant material and soil in tropical and subtropical areas. Without eye-drop treatment, which can last two to three months, the infection can scar the cornea and blind its victims. At least eight U.S. patients have required cornea transplants.

Extensive federal inspections of its factory in Greenville, S.C., where MoistureLoc was made for U.S. and several Asian markets, have not turned up evidence of "contamination, tampering, counterfeiting or sterility failure," Ron Zarrella, the eye-care product maker's chief executive, said in a statement.

"That leads us to conclude that some aspect of the MoistureLoc formula may be increasing the relative risk of Fusarium infection in unusual circumstances," he said. "We are continuing to investigate this link, but in the meantime, we're taking the

The recall is limited to MoistureLoc and does not involve other solutions in its ReNu line, including the older and more widely used MultiPlus brand — which some victims reported using.

Of the more than 30 million Americans who wear contact lenses, about 2.3 million use MoistureLoc, which was introduced in late 2004 and accounted for $100 million in global sales last year. Another 11 million people use the MultiPlus solution.

While the CDC reiterated that the origin remains a mystery, some eye specialists theorized that MoistureLoc's unique disinfecting and moisturizing agents could have played a role in the outbreak.

Bausch & Lomb Inc. said Monday it has permanently removed from markets worldwide a contact-lens solution that has been linked by health authorities to an outbreak of rare fungal infections that can cause blindness.


"Bausch & Lomb's top priority is the safety of our customers, and we want them to have complete confidence in our products," said the eye-care product maker's chief executive, Ronald Zarrella.

The Centers for Disease Control and Prevention said Friday that the number of confirmed cases of Fusarium keratitis in the United States has climbed to 122, most of them contact-lens wearers who reported using Bausch & Lomb's newest cleaner, ReNu with MoistureLoc MultiPurpose Solution.

The company halted U.S. sales of MoistureLoc on April 13 after the     CDC said it was investigating an unusual spike in infections in Americans using the product. The outbreak first surfaced in the Far East in the fall and infections have showed up most recently among contact-lens wearers in Europe.

The fungus is commonly found in plant material and soil in tropical and subtropical areas. Without eye-drop treatment, which can last two to three months, the infection can scar the cornea and blind its victims. At least eight U.S. patients have required cornea transplants.

Extensive federal inspections of its factory in Greenville, S.C., where MoistureLoc was made for U.S. and several Asian markets, have not turned up evidence of "contamination, tampering, counterfeiting or sterility failure," Zarrella said in a statement.

"That leads us to conclude that some aspect of the MoistureLoc formula may be increasing the relative risk of Fusarium infection in unusual circumstances," he said. "We are continuing to investigate this link, but in the meantime, we're taking the most responsible action in the interests of our customers by discontinuing the MoistureLoc formula.

"We are taking this action even in countries where we have seen no unusual trends in Fusarium infections, for example in China and the markets in Europe, the Middle East, and Africa," he added.

The recall is limited to MoistureLoc and does not involve other solutions in its ReNu line, including the older and more widely used MultiPlus brand — which some victims reported using.

Of the more than 30 million Americans who wear contact lenses, about 2.3 million use MoistureLoc, which was introduced in late 2004 and accounted for $100 million in global sales last year. Another 11 million people use the MultiPlus solution.

While the CDC reiterated that the origin remains a mystery, some eye specialists theorized that MoistureLoc's unique disinfecting and moisturizing agents could have played a role in the outbreak.
Bausch & Lomb Inc. said Monday it has permanently removed from markets worldwide a contact-lens solution that has been linked by health authorities to an outbreak of rare fungal infections that can cause blindness.


"Bausch & Lomb's top priority is the safety of our customers, and we want them to have complete confidence in our products," said the eye-care product maker's chief executive, Ronald Zarrella.

The Centers for Disease Control and Prevention said Friday that the number of confirmed cases of Fusarium keratitis in the United States has climbed to 122, most of them contact-lens wearers who reported using Bausch & Lomb's newest cleaner, ReNu with MoistureLoc MultiPurpose Solution.

The company halted U.S. sales of MoistureLoc on April 13 after the     CDC said it was investigating an unusual spike in infections in Americans using the product. The outbreak first surfaced in the Far East in the fall and infections have showed up most recently among contact-lens wearers in Europe.

The fungus is commonly found in plant material and soil in tropical and subtropical areas. Without eye-drop treatment, which can last two to three months, the infection can scar the cornea and blind its victims. At least eight U.S. patients have required cornea transplants.

Extensive federal inspections of its factory in Greenville, S.C., where MoistureLoc was made for U.S. and several Asian markets, have not turned up evidence of "contamination, tampering, counterfeiting or sterility failure," Zarrella said in a statement.

"That leads us to conclude that some aspect of the MoistureLoc formula may be increasing the relative risk of Fusarium infection in unusual circumstances," he said. "We are continuing to investigate this link, but in the meantime, we're taking the most responsible action in the interests of our customers by discontinuing the MoistureLoc formula.

"We are taking this action even in countries where we have seen no unusual trends in Fusarium infections, for example in China and the markets in Europe, the Middle East, and Africa," he added.

The recall is limited to MoistureLoc and does not involve other solutions in its ReNu line, including the older and more widely used MultiPlus brand — which some victims reported using.

Of the more than 30 million Americans who wear contact lenses, about 2.3 million use MoistureLoc, which was introduced in late 2004 and accounted for $100 million in global sales last year. Another 11 million people use the MultiPlus solution.

While the CDC reiterated that the origin remains a mystery, some eye specialists theorized that MoistureLoc's unique disinfecting and moisturizing agents could have played a role in the outbreak.

Photo

WASHINGTON , D.C. - The U.S. Consumer Product Safety Commission, in cooperation with the firm named below, today announced a voluntary recall of the following consumer product. Consumers should stop using recalled products immediately unless otherwise instructed.

Bausch & Lomb Inc. has permanently removed from markets worldwide a contact-lens solution that has been linked by health authorities to an outbreak of rare fungal infections that can cause blindness. Bausch & Lomb has proposed that unique characteristics of the formulation of the ReNu with MoistureLoc product in certain unusual circumstances can increase the risk of Fusarium infection.

Based on this scientific and epidemiological data suggesting that ReNu with MoistureLoc may increase susceptibility to Fusarium, Bausch & Lomb decided to permanently remove the ReNu with MoistureLoc product worldwide. FDA supports this decision. To date, data available do not indicate a problem with ReNu MultiPlus or ReNu Multi-Purpose or generic brands of this contact lens cleaning solution.

While FDA is still concluding its scientific evaluations and expects additional information to be submitted by the sponsor, at this time we recognize that Bausch & Lomb has proposed the formulation as the potential root cause of the increased relative risk of Fusarium keratitis associated with use of the ReNu with MoistureLoc product. FDA will continue to review cultures and epidemiological data and if there is new information that adds to or changes our current understanding, we will act on it in a timely and appropriate manner.

The Centers for Disease Control and Prevention claims that the number of confirmed cases of Fusarium keratitis in the United States has climbed to 122, most of them contact-lens wearers who reported using Bausch & Lomb's newest cleaner, ReNu with MoistureLoc MultiPurpose Solution.

The company halted U.S. sales of MoistureLoc on April 13 after the CDC said it was investigating an unusual spike in infections in Americans using the product. The outbreak first surfaced in the Far East in the fall and infections have showed up most recently among contact-lens wearers in Europe.

The fungus is commonly found in plant material and soil in tropical and subtropical areas. Without eye-drop treatment, which can last two to three months, the infection can scar the cornea and blind its victims. At least eight U.S. patients have required cornea transplants.

Extensive federal inspections of its factory in Greenville, S.C., where MoistureLoc was made for U.S. and several Asian markets, have not turned up evidence of "contamination, tampering, counterfeiting or sterility failure," Ron Zarrella, the eye-care product maker's chief executive, said in a statement.

"That leads us to conclude that some aspect of the MoistureLoc formula may be increasing the relative risk of Fusarium infection in unusual circumstances," he said. "We are continuing to investigate this link, but in the meantime, we're taking the

The recall is limited to MoistureLoc and does not involve other solutions in its ReNu line, including the older and more widely used MultiPlus brand — which some victims reported using.

Of the more than 30 million Americans who wear contact lenses, about 2.3 million use MoistureLoc, which was introduced in late 2004 and accounted for $100 million in global sales last year. Another 11 million people use the MultiPlus solution.

While the CDC reiterated that the origin remains a mystery, some eye specialists theorized that MoistureLoc's unique disinfecting and moisturizing agents could have played a role in the outbreak.

Bausch & Lomb Inc. said Monday it has permanently removed from markets worldwide a contact-lens solution that has been linked by health authorities to an outbreak of rare fungal infections that can cause blindness.


"Bausch & Lomb's top priority is the safety of our customers, and we want them to have complete confidence in our products," said the eye-care product maker's chief executive, Ronald Zarrella.

The Centers for Disease Control and Prevention said Friday that the number of confirmed cases of Fusarium keratitis in the United States has climbed to 122, most of them contact-lens wearers who reported using Bausch & Lomb's newest cleaner, ReNu with MoistureLoc MultiPurpose Solution.

The company halted U.S. sales of MoistureLoc on April 13 after the     CDC said it was investigating an unusual spike in infections in Americans using the product. The outbreak first surfaced in the Far East in the fall and infections have showed up most recently among contact-lens wearers in Europe.

The fungus is commonly found in plant material and soil in tropical and subtropical areas. Without eye-drop treatment, which can last two to three months, the infection can scar the cornea and blind its victims. At least eight U.S. patients have required cornea transplants.

Extensive federal inspections of its factory in Greenville, S.C., where MoistureLoc was made for U.S. and several Asian markets, have not turned up evidence of "contamination, tampering, counterfeiting or sterility failure," Zarrella said in a statement.

"That leads us to conclude that some aspect of the MoistureLoc formula may be increasing the relative risk of Fusarium infection in unusual circumstances," he said. "We are continuing to investigate this link, but in the meantime, we're taking the most responsible action in the interests of our customers by discontinuing the MoistureLoc formula.

"We are taking this action even in countries where we have seen no unusual trends in Fusarium infections, for example in China and the markets in Europe, the Middle East, and Africa," he added.

The recall is limited to MoistureLoc and does not involve other solutions in its ReNu line, including the older and more widely used MultiPlus brand — which some victims reported using.

Of the more than 30 million Americans who wear contact lenses, about 2.3 million use MoistureLoc, which was introduced in late 2004 and accounted for $100 million in global sales last year. Another 11 million people use the MultiPlus solution.

While the CDC reiterated that the origin remains a mystery, some eye specialists theorized that MoistureLoc's unique disinfecting and moisturizing agents could have played a role in the outbreak.
Bausch & Lomb Inc. said Monday it has permanently removed from markets worldwide a contact-lens solution that has been linked by health authorities to an outbreak of rare fungal infections that can cause blindness.


"Bausch & Lomb's top priority is the safety of our customers, and we want them to have complete confidence in our products," said the eye-care product maker's chief executive, Ronald Zarrella.

The Centers for Disease Control and Prevention said Friday that the number of confirmed cases of Fusarium keratitis in the United States has climbed to 122, most of them contact-lens wearers who reported using Bausch & Lomb's newest cleaner, ReNu with MoistureLoc MultiPurpose Solution.

The company halted U.S. sales of MoistureLoc on April 13 after the     CDC said it was investigating an unusual spike in infections in Americans using the product. The outbreak first surfaced in the Far East in the fall and infections have showed up most recently among contact-lens wearers in Europe.

The fungus is commonly found in plant material and soil in tropical and subtropical areas. Without eye-drop treatment, which can last two to three months, the infection can scar the cornea and blind its victims. At least eight U.S. patients have required cornea transplants.

Extensive federal inspections of its factory in Greenville, S.C., where MoistureLoc was made for U.S. and several Asian markets, have not turned up evidence of "contamination, tampering, counterfeiting or sterility failure," Zarrella said in a statement.

"That leads us to conclude that some aspect of the MoistureLoc formula may be increasing the relative risk of Fusarium infection in unusual circumstances," he said. "We are continuing to investigate this link, but in the meantime, we're taking the most responsible action in the interests of our customers by discontinuing the MoistureLoc formula.

"We are taking this action even in countries where we have seen no unusual trends in Fusarium infections, for example in China and the markets in Europe, the Middle East, and Africa," he added.

The recall is limited to MoistureLoc and does not involve other solutions in its ReNu line, including the older and more widely used MultiPlus brand — which some victims reported using.

Of the more than 30 million Americans who wear contact lenses, about 2.3 million use MoistureLoc, which was introduced in late 2004 and accounted for $100 million in global sales last year. Another 11 million people use the MultiPlus solution.

While the CDC reiterated that the origin remains a mystery, some eye specialists theorized that MoistureLoc's unique disinfecting and moisturizing agents could have played a role in the outbreak.

Photo


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