Product Recall: Hy-Care Multipurpose Solution – Mathieu Opticien

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PRODUCT RECALL

Hy-Care® Multipurpose Solution

Field Safety Corrective Action

Hy-Care® Multipurpose Solution

Dear Client,

Our supplier has advised a voluntary recall of Hy-Care® Multipurpose Solution for contact lenses (60ml & 360ml 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.

Considering the above note, Mathieu Opticiens recommends its clients to cease use of Hy-Care® Multipurpose Solution. If you are still using your Hy-Care® bottle, please return same to your nearest Mathieu Opticiens store. We shall then propose an alternative contact lens solution free of charge or shall proceed with a reimbursement.

Please contact: customercare@mathieu-opticians.mu for further information.

FREQUENTLY ASKED QUESTION

Why is our supplier recalling Hy-Care® Multipurpose Solution?

The quality testing has determined that the product may not offer appropriate levels of disinfection in some circumstances against high level 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?

Our supplier 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. Our supplier is taking this action in line with its 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 & 360ml). No other products from our supplier are included in this action.

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 our supplier, and this action is being undertaken voluntarily.

Could other CooperVision solutions also be affected?

No, this recall is specific to Hy-Care® Multipurpose Solution.

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 consumers who have Hy-Care® do with it?

Mathieu Opticiens clients who are still using Hy-Care® Multipurpose Solution should cease use but keep the bottle and send it back to the nearest Mathieu Opticiens store for any refund (exchange for an alternative contact lens solution free of charge or reimbursement).

Will the Hy-Care® brand return to the marketplace at some point?

We will keep you updated on this.