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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 Recall
AVAIRA Soft Contact Lenses
see related information
Date Posted January 03, 2013
Recall Status1 Terminated on May 09, 2014
Recall Number Z-0631-2013
Recall Event ID 63719
Premarket Notification
510(K) Number
K113759 
Product Classification Lenses, Soft Contact, Daily Wear - Product Code LPL
Product AVAIRA (enfilcon A) Soft (Hydrophilic) Daily Wear Toric Contact Lenses
Code Information 10447500016006, 10519550007006, 10537500016014
Recalling Firm/
Manufacturer
Cooper Vision Caribbean Corp.
#500 Road 584
Amuelas Industrial Park
Juana Diaz, Puerto Rico 00795
Manufacturer Reason
for Recall
The lenses exceeded the acceptance limit for silicone oil residual.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Material/Component Contamination
Action The 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 Commerce 246
Distribution US Nationwide, including Puerto Rico, and Canada.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LPL and Original Applicant = COOPERVISION, INC.
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