Recall Z-0164-05 ยท MVN Lens, Contact, (Disposable)
1-800 Contacts Inc.
Counterfeit contact lenses labeled as: 'CooperVision Proclear compatibles (omafilcon A)'. Labeling on outer box reads in part: 'CooperVision proclear compatibles (omafilcon A) ***Norfolk, VA *** MADE IN USA ** Tinted soft contact lenses *** in a buffered 0.9% saline solution***''.
| Date | Nov 3, 2004 (initiated Oct 13, 2004) |
| Status | Terminated |
| Reason | Identified lots of Proclear Compatible contact lenses are counterfeit and may not be sterile. |
| Root cause | Other |
| Action | Identified lots of CooperVision Proclear Compatibles contact lenses are counterfeit and non-sterile. |
| Quantity | 82,268 |
| Distribution | Product distributed to customers nationwide and internationally. Product distributed in US and to Canada, England, New Zealand, New Foundland, British columbia,Guam, Egypt, Greece, Japan, Ireland and Autralia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.