Recall Z-0542-2014 ยท MVN Lens, Contact, (Disposable)
CooperVision Inc.
Pro clear(R) 1 day Sphere (o mafilcon A), 90 daily disposable contact lenses, STERILE, Rx ONLY --- Coopervision Shamble, SO 31 4 RF, UK - Scottsville, NY 14546 USA - Juana Diaz, PR 00795 USA daily use disposable contact lenses
| Date | Dec 19, 2013 (initiated Nov 20, 2013) |
| Status | Terminated |
| Reason | Lots were labeled with incorrect expiration dates on secondary package (carton). The primary package (blister) is marked with the correct expiration date. |
| Root cause | Incorrect or no expiration date |
| Action | CooperVision sent an Urgent Medical Device Recall Letters dated November 20, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. Our records indicate you received some of the affected product. Enclosed you will find a list of affected carton lot numbers, with the correct expiration date, that were shipped to your account. " Please immediately examine your inventory, " Stop any further distribution of carton(s) subject to the recall, " Quarantine carton(s) with incorrect expiration date, and " CooperVision will mak |
| Quantity | 153 cartons |
| Distribution | Worldwide Distribution - USA (nationwide) and the countries of Aruba, Canada, Colombia and Trinidad. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061948 | PROCLEAR (OMAFILCON A) DAILY DISPOSABLE/DAILY WEAR SOFT CONTACT LENS CooperVision, Inc., Nov 22, 2006 |