AVAIRA (enfilcon A) Soft (Hydrophilic) Daily Wear Toric Contact Lenses
Class I - Dangerous 🏥 Medical Devices
Recalled: November 9, 2012 Cooper Vision Caribbean Other Medical Devices
Nationwide
What Should You Do?
- Check if you have this product: 10447500016006, 10519550007006, 10537500016014
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Cooper Vision Caribbean Corp.
- Reason for Recall:
- The lenses exceeded the acceptance limit for silicone oil residual.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
AVAIRA (enfilcon A) Soft (Hydrophilic) Daily Wear Toric Contact Lenses
Product Codes/Lot Numbers:
10447500016006, 10519550007006, 10537500016014
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0631-2013
Related Recalls
Soft Contact Lens
Cooper Vision Caribbean
Class I - Dangerous
Portions of the lots may contain units with an incorrect lens axis condition.
Class I - Dangerous
Routine quality monitoring system has identified that a limited number of lots were manufactured with the cylinder axis outside the allowable specification.