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Permanent Recall of Contact Lens Solution
This update is adapted from information released by the American Academy of Ophthalmology:
Bausch & Lomb has told the U.S. Food and Drug Administration (FDA) that based on scientific and epidemiological data, unique characteristics of the formulation of ReNu with MoistureLoc in certain unusual circumstances can increase the risk of Fusarium infection.
Bausch & Lomb's other ReNu products, including MultiPlus and Multi-Purpose, are not included in the recall. To date, data available do not indicate a problem with these products or generic brands of this contact lens cleaning solution.
Saying it's the "right thing to do," Bausch & Lomb Chairman and CEO Ron Zarrella today issued the worldwide recall. He said his company will not reintroduce the product.
In a letter to consumers, Zarrella wrote: "After thousands of tests, there is no evidence of MoistureLoc contamination, tampering or counterfeiting. That leads us to conclude that there may be some aspect of the MoistureLoc formula, when combined with certain environmental factors, lens wear and care practices, and other factors, that might increase the risk of Fusarium infection in rare circumstances."
Baush & Lomb implicates alexidine, a disinfecting agent added to MoistureLoc. The company claims that alexidine is safe and effective, but under certain extreme conditions - such as when the solution is allowed to evaporate, when the solution is not regularly replaced in the lens case, when the bottle is kept open in between uses, or when the case is not cleaned properly or changed regularly the solution is more likely to be contaminated with Fusarium in the environment.
The FDA today said it supported Bausch & Lomb's global recall, and planned to issue findings "imminently" from an inspection of Bausch & Lomb facilities in Greenville, S.C. The U.S. Centers for Disease Control and Prevention has received reports of more than 120 confirmed cases of Fusariuim keratitis as of May 12. An additional 60 cases are under investigation, and 15 are listed as "possible."
Related Topics: Contact Lens Solution, Eye Fungus Risk, New Contact Lenses, Old Infection Risk
Bausch & Lomb has told the U.S. Food and Drug Administration (FDA) that based on scientific and epidemiological data, unique characteristics of the formulation of ReNu with MoistureLoc in certain unusual circumstances can increase the risk of Fusarium infection.
Bausch & Lomb's other ReNu products, including MultiPlus and Multi-Purpose, are not included in the recall. To date, data available do not indicate a problem with these products or generic brands of this contact lens cleaning solution.
Saying it's the "right thing to do," Bausch & Lomb Chairman and CEO Ron Zarrella today issued the worldwide recall. He said his company will not reintroduce the product.
In a letter to consumers, Zarrella wrote: "After thousands of tests, there is no evidence of MoistureLoc contamination, tampering or counterfeiting. That leads us to conclude that there may be some aspect of the MoistureLoc formula, when combined with certain environmental factors, lens wear and care practices, and other factors, that might increase the risk of Fusarium infection in rare circumstances."
Baush & Lomb implicates alexidine, a disinfecting agent added to MoistureLoc. The company claims that alexidine is safe and effective, but under certain extreme conditions - such as when the solution is allowed to evaporate, when the solution is not regularly replaced in the lens case, when the bottle is kept open in between uses, or when the case is not cleaned properly or changed regularly the solution is more likely to be contaminated with Fusarium in the environment.
The FDA today said it supported Bausch & Lomb's global recall, and planned to issue findings "imminently" from an inspection of Bausch & Lomb facilities in Greenville, S.C. The U.S. Centers for Disease Control and Prevention has received reports of more than 120 confirmed cases of Fusariuim keratitis as of May 12. An additional 60 cases are under investigation, and 15 are listed as "possible."
Related Topics: Contact Lens Solution, Eye Fungus Risk, New Contact Lenses, Old Infection Risk
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