Enforcement Report - Week of January 9, 2013
-
Back to Previous Page
Product Detail
| Product Description | AVAIRA (enfilcon A) Soft (Hydrophilic) Daily Wear Toric Contact Lenses |
|---|---|
| Recall Number | Z-0631-2013 |
| Classification | Class II |
| Code Info | 10447500016006, 10519550007006, 10537500016014 |
| Product Distributed Qty | 246 |
| Reason For Recall | The lenses exceeded the acceptance limit for silicone oil residual. |
Event Detail
| Event Id | 63719 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Cooper Vision Caribbean Corp. |
| City | Juana Diaz |
| State | PR | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-11-09 |
| Initial Firm Notification of Consignee or Public | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
| Distribution Pattern | US Nationwide, including Puerto Rico, and Canada. |
-
