Update

CooperVision Announces FDA Special 510(k) Clearance
on Avaira® Toric Contact Lenses

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CooperVision Sofmed Breathables® Contact Lens Recall

We have initiated a recall of a limited number of Sofmed Breathables and Sofmed Breathables Toric 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 you experience hazy vision or unusual discomfort with your Sofmed Breathables lenses, please remove your lenses immediately and contact your eye care practitioner. You can check to see if your lenses are part of the limited recall by checking the lot number as indicated below. If your lenses are affected even if you’re not experiencing symptoms please contact your eye care professional.

What happened?

The recall was initiated due to the level of a residue on certain Sofmed Breathables 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 Sofmed Breathables lenses?

Below, please enter the Lot Number for your Sofmed Breathables 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.

Invalid lot number.

Lot numbers are numeric and between 14 and 18 digits long. Please review your entry.

Your lenses are affected by the recall.

Sofmed Breathables wearers: Did you purchase them from your Eye Care Practitioner or an Online Retailer?

Sofmed Breathables Toric wearers: Did you purchase them from your Eye Care Practitioner or an Online Retailer?

Your lenses are not affected by the recall.

No further action is required. Thank you.

We apologize for any inconvenience this recall may cause you and are working hard to make this process as smooth and easy as possible. If you would like more information on the Avaira lens recall, please read through the questions and answers below.

If you have any further questions about the recall, please read through the below Q&A or contact us with your question or concern.

Questions & Answers About The Recall

  • What is the cause of the Sofmed Breathables and Sofmed Breathables Toric recall?
  • The recall was initiated on limited lots of Sofmed Breathables and Sofmed Breathables Toric 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.
  • What happens if a contact lens wearer puts an impacted lens in their eye?
  • We have received complaint reports for the Sofmed Breathables 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 Sofmed Breathables 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 your 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 Sofmed Breathables andSofmed Breathables Toric 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 1-855-526-6737.
  • Will I be able to re-order my Sofmed Breathables and Sofmed Breathables Toric lenses?
  • We expect that Sofmed Breathables Toric will be available for ordering in the second quarter of 2012. We anticipate minimal disruption to availability of Sofmed Breathables and you can continue to order through your practitioner.

    Still Have Questions? Please consult our Customer Care Center by calling 1-855-5-COOPER
    (1-855-526-6737) or emailing consumercare@coopervision.com. (Consumer Care hours of operation are 9:00AM - 5:00PM ET Mon-Fri).