Hy-Care^® Product Recall  

CooperVision^® Hy-Care^® and Pure® Multltipurpose contact lens solution  

We have been advised of a voluntary recall by contact lens solutions manufacturer, CooperVision, of Hy-Care^® and Pure® multipurpose contact lens solution (60ml,100ml, 250ml bottles).  

The manufacturer’s quality testing 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, this action is out of an abundance of caution.  

The manufacturer will shortly be setting up a website where users of the product can go for information on what to do and how to be reimbursed. We will contact you / please check this website for confirmation of when the recall website is live.  

It is important you continue to clean and disinfect your soft contact lenses. Please cease use and discard your HyCare and Pure® multipurpose contact lens solution once you have secured an alternative multipurpose solution. Please retain the bottle in order to obtain your reimbursement through the recall website.  

Multipurpose Solution – Field Safety Corrective Action  

FREQUENTLY ASKED QUESTIONS AND ANSWERS  

Why is CooperVision recalling Hy-Care^® multipurpose solution?
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.

Does Hy-Care^® pose any danger to someone if used?
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.

Have there been any adverse events, injuries, or complaints reported?
We have received no complaints and there have been no confirmed incidents attributed to inadequate disinfection. 

Which brands are affected?
The withdrawal affects all configurations of Hy-Care^® multipurpose solution (60ml, 100ml, 250ml). No other CooperVision products are included in this action.  

Are private label variants of Hy-Care^® affected?  

Yes, they are included in the recall.  

What countries are included in the recall?
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*  

Zimbabwe*.  

*Awaiting confirmation of whether in scope.  

Is the recall a mandated or voluntary action?
The highest standards of product quality is a priority for CooperVision, and this action is being undertaken voluntarily.

Has the company notified the appropriate competent authorities?
Communications with the relevant authorities is underway and will occur within the required deadlines.
 

Could other CooperVision solutions also be affected?
No, this recall is specific to Hy-Care^® multipurpose solution.

Do any other CooperVision solutions use this formulation?  

No, this formulation is specific to Hy-Care^®.

Can you be more specific regarding how disinfection performance lagged?
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.   

Was there a certain bacteria or fungus against which the solution was ineffective?  

Yes, Candida albicans, on certain lens types – group IV (hydrogel) and group V(A) (a subset of silicone hydrogel) lenses.

What should patients who have Hy-Care^® do with it?
Patients who have Hy-Care^® solution should cease use, but keep the bottle. We are preparing a website that will have further information with instructions on what patients should do, including reimbursement.  

Why isn’t that available now?  

We have acted swiftly to notify relevant competent authorities and customers of our actions. We did not want to delay this while we created the website for patients.

Will the Hy-Care^® brand return to the marketplace at some point?
We will keep you updated on this.