FDAClass IIJanuary 9, 2013

Avaira recall

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

Why was Avaira recalled?

The lenses exceeded the acceptance limit for silicone oil residual.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

10447500016006, 10519550007006, 10537500016014

Product
AVAIRA (enfilcon A) Soft (Hydrophilic) Daily Wear Toric Contact Lenses
Recalling firm
Cooper Vision Caribbean Corp.
Quantity
246
Distribution
US Nationwide, including Puerto Rico, and Canada.
Recall date
January 9, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls