Q: Why is CooperVision recalling Hy-Care® multipurpose solution?
A: Our quality testing has determined that the product may not offer appropriate levels of disinfection in some circumstances against high levels of a particular yeast organism. Although no complaints have been received and there have been no confirmed incidents attributed to inadequate disinfection, we are acting out of an abundance of caution.
Q: Does Hy-Care® pose any danger to someone if used?
A: We have received no complaints and there have been no confirmed incidents attributed to inadequate disinfection. However, the product may not be effective to the standards we expect if a lens is contaminated with high levels of a particular yeast organism. We are taking this action in line with our quality standards and out of an abundance of caution.
Q: Have there been any adverse events, injuries, or complaints reported?
A: We have received no complaints and there have been no confirmed incidents attributed to inadequate disinfection.
Q: Which brands are affected?
A: The withdrawal affects all configurations of Hy-Care® multipurpose solution (60ml, 100ml, 250ml, 360ml, 380ml). No other CooperVision products are included in this action.
Q: Are private label variants of Hy-Care® affected?
A: Yes, they are included in the recall.
Q: What countries are included in the recall?
A: The affected bottles were shipped to:
Andorra, Argentina, Aruba, Austria, Belarus, Belgium, Bolivia, Botswana, Bulgaria, Chile, Costa Rica, Cyprus, Czech Republic, Denmark, Ecuador, Finland, France, Georgia, Germany, Greece, Greenland, Guernsey (UK), Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Jersey (UK), Jordan, Kenya, Latvia, Lesotho, Lithuania, Luxembourg, Malta, Mauritius, Mozambique, Namibia, Netherlands, Netherlands Antilles, Norway, Paraguay, Poland, Portugal, Qatar, Russia, San Marino, Saudi Arabia, Serbia, Seychelles, Slovakia, Slovenia, South Africa, Spain, Suriname, Swaziland, Sweden, Switzerland
Tanzania, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Zambia
Q: Is the recall a mandated or voluntary action?
A: The highest standards of product quality is a priority for CooperVision, and this action is being undertaken voluntarily.
Q: Has the company notified the appropriate competent authorities?
A: Communications with the relevant authorities is underway and will occur within the required deadlines.
Q: Could other CooperVision solutions also be affected?
A: No, this recall is specific to Hy-Care® multipurpose solution.
Q: Do any other CooperVision solutions use this formulation?
A: No, this formulation is specific to Hy-Care®.
Q: Can you be more specific regarding how disinfection performance lagged?
A: Laboratory testing indicated that the product may not be effective to the standards we expect if a lens is contaminated with high levels of a particular yeast organism.
Q: Was there a certain bacteria or fungus against which the solution was ineffective?A: Yes, Candida albicans, on certain lens types - group IV (hydrogel) and group V(A) (a subset of silicone hydrogel) lenses.
Q: What should consumers who have Hy-Care® do with it?
A: Consumers who have Hy-Care® solution should cease use once they have secured an alternative multipurpose solution, but keep the bottle.
Q: Will the Hy-Care® brand return to the marketplace at some point?
A: We will keep you updated on this.
Q: How have you only discovered this issue now as you’ve been selling the product for many years?
A: CooperVision’s regulatory and quality processes recently highlighted a need for additional testing to confirm product disinfection efficacy. It was through this testing that it was identified that the product may not offer appropriate levels of disinfection for certain lens types against high levels of a particular yeast organism.