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Avaira (enfilcon A) Sphere contact lenses
Urgent medical device recall
|Date agreed:||17 November 2011|
Avaira (enfilcon A) Sphere Contact Lenses.
The Avaira Sphere Contact Lenses are also marketed under the following brand names:
|Batch number:||Various (see instructions below)|
|Sponsor:||CooperVision Australia Pty Ltd|
|Contact:||1800 722 310 - CooperVision Customer Service|
|Reason:||This recall is an expansion to the scope of the previous recall of Avaira Toric Contact Lenses which occurred in August 2011. Specific lots of an additional contact lens model i.e., Avaira Sphere Contact Lens have been identified as being affected by the unintended presence of a residue identified as silicone oil.|
If you have this product you can check whether the lot number you have is included in the recall by contacting CooperVision Customer Service on free call 1800 722 310, visiting their website http://recall.coopervision.com/us.html, or contacting your place of purchase.
Please refer to the TGA safety alert for more detailed information.
Class I defects are potentially life-threatening or could cause a serious risk to health.
Class II defects could cause illness or mistreatment, but are not Class I.
Class III defects may not pose a significant hazard to health, but withdrawal may be initiated for other reasons.
Class I & II recalls are considered to be safety related recalls.