FDAFDA · Food and drugs·Recall number Z-0631-2013
AVAIRA (enfilcon A) Soft (Hydrophilic) Daily Wear Toric Contact Lenses
Published January 9, 2013 · Recall initiated: November 9, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The lenses exceeded the acceptance limit for silicone oil residual.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Cooper Vision Caribbean Corp.
- Distributor
- US Nationwide, including Puerto Rico, and Canada.
- Lot
- 10447500016006, 10519550007006, 10537500016014
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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