Avaira recall (ECP) | CooperVision

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CooperVision Avaira^® Contact Lens Recall

We have 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 any of your patients experience hazy vision or unusual discomfort with Avaira lenses, please have them remove the lenses immediately. You can check to see if the lenses are part of the limited recall by checking the lot number as indicated below.

What happened?

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

We sincerely apologize 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 we take our consumers’ eye health and safety very seriously. We strive to ensure all wearers have a positive experience with our products.

Does this affect my Avaira lenses?

Below, please enter the Lot Number for your Avaira lenses, which can be found on the packaging (box) or on the blister (package). After entering your Lot Number and clicking “search,” you will be notified as to whether or not your lenses are affected.

If you have any further questions about the recall, please read through the Q&A below for more detailed information.

Questions & Answers About The Recall

What was the cause of the original Avaira Toric recall?: The Company received complaints of hazy vision, and immediately began an investigation of Avaira Toric lenses. The company identified the presence of a residue (silicone oil) on the lens. Because we take the health and safety of patients seriously, CooperVision began the recall process.
In your original communications regarding the Avaira Toric limited lot recall, you indicated that Avaira Sphere was not impacted. Why was that?: The manufacturing issue with the Avaira Toric lenses is isolated to the Avaira Toric production line. Once we resolved the immediate concern with the Avaira Toric lenses, we completed a comprehensive evaluation of all Avaira manufacturing lines and identified a level of residue (silicone oil) on certain lots of Avaira Sphere lenses that did not meet our updated quality requirements.
Why are you issuing a limited lot recall for Avaira Sphere now? What changed?: This is an expansion of the current Avaira Toric recall involving limited lots of Avaira Sphere contact lenses. As part of our commitment to quality and customer satisfaction, CooperVision completed a comprehensive investigation of all Avaira manufacturing lines and identified a level of residue (silicone oil) on some lots of Avaira Sphere that did not meet our updated quality requirements. We made the decision to expand the recall in the interests of the continued health and safety of our customer’s eyes.
How can CooperVision be certain that all affected Avaira Sphere lots have been identified?: We have incorporated and completed quality control analyses and reconciliation steps throughout manufacturing and distribution which give us confidence that the list of impacted lots is complete.
What is the cause of the level of residue (silicone oil) found on the impacted Avaira Sphere lots?: The residue on the Avaira Sphere lens was due to a manufacturing error that has been corrected through quality system process. CooperVision identified certain lots of Avaira Sphere lenses that did not meet its updated quality requirements due to the level of a residue (silicone oil) and began the recall process.
In your original communications regarding the Avaira Toric limited lot recall, you indicated that Avaira Toric utilizes a different manufacturing process than Avaira Sphere. Was that an incorrect statement?: No. The manufacturing issue with the Avaira Toric lenses is isolated to the Avaira Toric production line. Once we resolved the immediate concern with the Avaira Toric lenses, we completed a comprehensive evaluation of all Avaira manufacturing lines and identified a level of residue (silicone oil) on certain lots of Avaira Sphere that did not meet our updated quality requirements. CooperVision has identified the issue and has corrected it through its quality system processes.
Are you continuing to manufacture Avaira Sphere?: Yes, we anticipate minimal impact on supply.
What happens to a patient if they put an impacted lens in their eye?: We have 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 a patient presents with these symptoms?: Have the patient remove the lenses from their eyes immediately. As their eye care practitioner, we request that you diagnose and treat their symptoms. If the lens is removed promptly after the onset of symptoms, it likely the symptoms will clear up within 15 to 30 minutes. If the patient leaves the lens for a prolonged period of time the symptoms may progress to more serious conditions.
Is Avaira Toric or Avaira Sphere being discontinued as a result of the recall?: No. We expect that Avaira Toric will be available for ordering in the 2Q of 2012. There is minimal disruption to availability of Avaira Sphere and we continue to ship product to distributors and customers.
What should be done with my Avaira Toric fitting set?: Please discontinue use of your Avaira Toric fitting set. A CooperVision sales representative will be visiting your office to remove the old fitting set and will replace it with a new fitting set at a later date.
What should be done with my Avaira Sphere fitting set?: If your Avaira Sphere fitting set contains impacted lenses, you will be notified and we will work with you to remove and replace the impacted trial lenses.
When can I start ordering product again?: We expect that Avaira Toric will be available for ordering in the 2Q of 2012. There is minimal disruption to availability of Avaira Sphere and we continue to ship product to distributors and customers..
I order Avaira Toric and Avaira Sphere through my distributor. Do they have affected product?: The distributors have been notified and they are identifying the affected lots of Avaira Toric and Avaira Sphere in their distribution centers.
When can I start ordering new product from my distributor again?: We expect that Avaira Toric will be available for ordering in the second quarter of 2012. There is minimal disruption to availability of Avaira Sphere and you can continue to place orders with your distributor.
Why can you ship Avaira Sphere but you are not shipping Avaira Toric?: There is only one line that makes Avaira Toric so this caused supply chain problems. Avaira Sphere is manufactured on three lines.
Should I be contacting my patients about the Avaira Toric or Avaira Sphere recall?: Yes. If you would like assistance with this activity please contact a CooperVision representative or customer service at 1.800.341.2020 and we will be able to provide you with pre-paid postage postcards. You can also direct your patients to www.coopervision.com/recall to check their contact lens lot numbers or call consumer support at 1.855.526.6737.
Do you have recommendations of other toric products if Avaira Toric is not available?: Yes. CooperVision Biofinity Toric, is an excellent alternative product to Avaira Toric. Biofinity Toric has a similar lens design and is also a silicone hydrogel material. You may already have a Biofinity Toric fitting set to use. If you do not, but would like one, please contact your CooperVision Representative or call 1.800.341.2020.

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