Recall Z-0631-2013 ยท LPL Lenses, Soft Contact, Daily Wear
Cooper Vision Caribbean Corp.
AVAIRA (enfilcon A) Soft (Hydrophilic) Daily Wear Toric Contact Lenses
| Date | Jan 3, 2013 (initiated Nov 9, 2012) |
| Status | Terminated |
| Reason | The lenses exceeded the acceptance limit for silicone oil residual. |
| Root cause | Material/Component Contamination |
| Action | 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. |
| Quantity | 246 |
| Distribution | US Nationwide, including Puerto Rico, and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K113759 | AVAIRA (ENFILCON A) CONTACT LENS CooperVision, Inc., Apr 3, 2012 |