CooperVision Expanding Global Recall Of Contact Lenses

Editor's Choice
Main Category: Eye Health / Blindness
Also Included In: Medical Devices / Diagnostics
Article Date: 16 Nov 2011 - 19:00 PST


Some lots of Avaira Sphere contact lenses have been added to CooperVision's global recall of the Avaira brand product line. The company says the level of silicone oil residue in some Avaira Sphere lens lots did not meet its updated quality requirements. Silicon oil on the contact lens can cause discomfort, eye pain, hazy vision, and even eye injuries that require medical attention.

CooperVision is working closely with the Food and Drug Administration (FDA), the Agency announced.

Christine Moench, Vice President, Global Regulatory Affairs and Quality Assurance, CooperVision, said:

"The company is confident we found the problem and have taken corrective action to fix the problem. The health and safety of our customers is our top priority."

Any customers who experience symptoms described above and are wearing Avaira Sphere contact lenses should take them out straight away and contact their eye care practitioner.

Customers with Avaira Sphere contact lenses should:

• Enter the package lot number on the contact lens carton or blister label to find out if their lens is included in this current recall. Go to www.coopervision.com/international-recall to find out.
  
  
  This picture shows where lot numbers can be found
  
• The following telephone number is available as an alternative way of determining whether the lot number of your product forms part of this recall. (USA) 1-855-526-6737 (9.00am to 5.00pm EST Monday-Friday)
• Customers who have lenses that form part of this recall should return them to where they bought them or to their eye care practitioner
• Patients or health care practitioners who identify adverse events related to the use of this product are invited to report them to the FDA's MedWatch Adverse Event Reporting program via the following routes:
  
  - online www.fda.gov/MedWatch/report.htm
  
  - by regular post, details can be found at www.fda.gov/MedWatch/report.htm. (A postage-paid, pre-addressed Form FDA 3500)
  
  - by Fax to: (USA) 1-800-FDA-0178

In August of this year, the company recalled some lots of Avaira Toric contact lenses. CooperVision says it has identified and corrected the source of the problem that triggered the recall.

Avaira Sphere lenses that do not form part of this recall will continue being shipped.

CooperVision is asking eye care practitioners to inform their patients about this expanded recall.

Written by Christian Nordqivst
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today

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