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CooperVision expands Avaira® CL recall

November 17, 2011

CooperVision has initiated a recall of a limited number of Avaira Toric and Avaira Sphere contact lenses after discovering reports of wearers experiencing hazy vision and discomfort. Some patients reported severe eye pain or eye injuries requiring medical treatment. Not everyone experiences the same symptoms.

If patients experience hazy vision or unusual discomfort with their Avaira lenses, they should remove the lenses immediately. Patients and practitioners can check to see if lenses are part of the limited recall by checking the lot number as indicated below. If lenses are affected, even if a patient is not experiencing symptoms, they should contact their eye care professional.

What happened?

The recall was initiated due to the level of a residue on certain Avaira lenses.

CooperVision said it sincerely apologizes to those customers who have experienced problems with the affected lenses or have the affected lenses in their possession. CooperVision has more than 30 years of experience manufacturing high quality contact lenses, and said it takes consumers’ eye health and safety very seriously.

To check the lot number of contact lenses, visit www.coopervision.com/recall.

Questions & Answers About The Recall

      • What is the cause of the Avaira Toric and Avaira Sphere recall?

The recall was initiated on limited lots of Avaira Toric and Avaira Sphere because CooperVision identified certain lots that did not meet updated quality requirements due to the level of a residue (silicone oil). The presence of the residue may cause hazy vision or discomfort, severe eye pain or eye injuries requiring medical treatment. Not everyone experiences the same symptoms.

      • What happens if contact lens wearers put impacted lenses in their eyes?

CooperVision has received complaint reports for the Avaira Toric lenses that began as hazy vision. After the recall, some patient complaints were received that began as hazy vision but progressed to severe eye pain or eye injuries requiring medical treatment. Not every patient has the same symptoms. Health and safety of patients are our top priority so the recall was expanded to the limited lots of Avaira Sphere lenses.

      • What should I do if I personally experience these symptoms?

Remove the lenses from your eyes immediately if you are currently wearing them. Contact an eye care practitioner to let them know you are experiencing symptoms. Follow your eye care practitioner’s instructions.

      • If I have symptoms, how long will they last?

If the lens is removed promptly after the onset of symptoms it likely will clear up within 15 to 30 minutes. If you leave the lens in your eye for a prolonged period of time, the symptoms may progress to a more serious condition. Contact your eye care practitioner to let them know you are experiencing symptoms.

      • Has anyone had permanent damage to their eye because of these symptoms?

To date we have not received any reports of permanent damage to a patient’s eye after wearing the affected lens.

      • What should be done with product that I currently have at home?

A small percentage of Avaira Toric and Avaira Sphere lenses are affected by this situation. Please check the lot number on the carton or blister label you have by using the search box above to see if your product has been impacted by the recall, and if so, discontinue wear and return the lenses to your eye care practitioner. You may also call our Consumer Care hotline at 855-526-6737.

      • Will I be able to re-order my Avaira Toric and Avaira Sphere lenses?

We expect that Avaira Toric will be available for ordering in the second quarter of 2012. We anticipate minimal disruption to availability of Avaira Sphere and you can continue to order through your practitioner.

Any adverse events that may be related to the use of this product should be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

The total number of Avaira Sphere lenses manufactured that are affected by the recall is 6.6 million, of which 4.9 million were shipped to customers globally. CooperVision intends to replace the recalled product with available Avaira Sphere inventory from lots that are not impacted by this recall action.

Still Have Questions?
Please consult our Customer Care Center by calling 855-5-COOPER (855-526-6737) or e-mailing

consumercare@coopervision.com

. (Consumer Care hours of operation are 9 a.m. – 5 p.m. EST Monday-Friday).
 

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