AVAIRA (enfilcon A) Soft (Hydrophilic) Daily Wear Toric Contact Lenses
FDA Recall Z-0631-2013 · Posted 2013-01-03
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Recalling FirmCooper Vision Caribbean Corp.
Recall StatusTerminated
Product CodeLPL
Date Initiated2012-11-09
Date Terminated2014-05-09
Product Quantity246
Reason for Recall
The lenses exceeded the acceptance limit for silicone oil residual.
Firm 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.
Root Cause
Material/Component Contamination
Distribution Pattern
US Nationwide, including Puerto Rico, and Canada.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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