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U.S. Department of Health and Human Services

Class 2 Device Recall AVAIRA Soft Contact Lenses

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 Class 2 Device Recall AVAIRA Soft Contact Lensessee related information
Date Initiated by FirmNovember 09, 2012
Date PostedJanuary 03, 2013
Recall Status1 Terminated 3 on May 09, 2014
Recall NumberZ-0631-2013
Recall Event ID 63719
510(K)NumberK113759 
Product Classification Lenses, soft contact, daily wear - Product Code LPL
ProductAVAIRA (enfilcon A) Soft (Hydrophilic) Daily Wear Toric Contact Lenses
Code Information 10447500016006, 10519550007006, 10537500016014
FEI Number 3002911336
Recalling Firm/
Manufacturer		 Cooper Vision Caribbean Corp.
#500 Road 584
Amuelas Industrial Park
Juana Diaz PR 00795
Manufacturer Reason
for Recall		The lenses exceeded the acceptance limit for silicone oil residual.
FDA Determined
Cause 2		Material/Component Contamination
ActionThe recall was conducted to the wholesale/distributor and Eye Care Practitioner level. The company contacted the Authorized Distributors by telephone, followed by written notification dated November 9, 2012. All written notifications to first consignees, for both revenue and Fit Sets, were sent by overnight mail with signature required as proof of receipt and the envelopes were marked "Urgent". The notifications described the issue and provided recommended actions. Customers may contact 800-341-2020 if questions.
Quantity in Commerce246
DistributionUS Nationwide, including Puerto Rico, and Canada.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
510(K) Database510(K)s with Product Code = LPL
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