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Avaira (enfilcon A) Sphere contact lenses

Related information

Urgent medical device recall

18 November 2011
Level: Consumer
Class: II
Reference: RC-2011-RN-01119-3
Date agreed: 17 November 2011
Product:

Avaira (enfilcon A) Sphere Contact Lenses.

The Avaira Sphere Contact Lenses are also marketed under the following brand names:

  • Clear Choice Premium Plus 14 Day Sphere
  • Prevue Platinum Sphere
  • ProActive Premium Sphere
  • VisionPlus Fortnightly Sphere
  • Softview Fortnightly Plus Sphere
  • See and Save Premium 2 Week Sphere
  • Trio2 Premium 2 Week Sphere
  • Ascend Evolve Sphere
  • Betaview 2 Weekly SphereEasyvision elite fortnightly Sphere
ARTG number: 97180
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.

Classification system:

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.