Friday, November 18, 2011

November 17, 2011 Update: encore100® Toric and encore100® Sphere Limited Lot Recall Q&As

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From the Cooper Vision Site:

encore100® Toric and encore100® Sphere Limited Lot Recall Q&As

Q: What is the cause of the encore100 Toric and encore100 Sphere recall?
A: The recall was initiated on limited lots of encore100 Toric and encore100 Sphere because
CooperVision identified certain lots that did not meet our 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.

Q: What happens if a contact lens wearer puts an impacted lens in their eye?

A: We have received complaint reports for the encore100 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 encore100 Sphere lenses.

Q: What should I do if I personally experience these symptoms?

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

Q: If I have symptoms how long will they last?

A: 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.

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

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

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

A: A small percentage of encore100 Toric and encore100 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 on the www.coopervision.com/international-recalll website 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 1-855-526-6737.

Q: Will I be able to re-order my encore100 Toric and encore100 Sphere lenses?

A: We expect that encore100 Toric will be available for ordering in the spring of 2012.  We anticipate
minimal disruption to availability of encore100 Sphere and you may continue to order through your
practitioner.

http://coopervision.com/pv_obj_cache/pv_obj_id_B84970CE53ADAF9E19484A5FD2C6ABD949630000/filename/encore100_Toric_and_encore100_Sphere_Consumer_FAQs_v7.pdf

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