FDA · Medical device recall

AVAIRA (enfilcon A) Soft (Hydrophilic) Daily Wear Toric Contact Lenses

Jan. 9, 2013 Class II

Date: Jan. 9, 2013
Risk class: Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
Status: Terminated
Filed by: Cooper Vision Caribbean Corp.
Product: AVAIRA (enfilcon A) Soft (Hydrophilic) Daily Wear Toric Contact Lenses
Reason: The lenses exceeded the acceptance limit for silicone oil residual.
Distribution pattern: US Nationwide, including Puerto Rico, and Canada.
Quantity: 246
Codes and lots: 10447500016006, 10519550007006, 10537500016014
Recall started: Nov. 9, 2012
Device type: Lenses, Soft Contact, Daily Wear
Root cause (FDA): Material/Component Contamination
What the company told customers: 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.
Recall number: Z-0631-2013

Source: FDA · Medical device enforcement report, recall number Z-0631-2013. The agency record governs; check it and the company before acting.

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