Recall Z-0125-2010 ยท MVN Lens, Contact, (Disposable)
CooperVision Inc.
ClearSight(TM) 1-Day (ocufilcon D) Toric 30 daily disposable contact lenses for astigmatism --- Name and Address on Label: CooperVision Hamble, SO31 4RF, UK, and Scottsville, NY 14546 USA --- Each lens is supplied sterile in a blister containing buffered saline solution. The blister is labeled with the base curve, diameter, dioptric power, manufacturing lot number, and expiration date of the lens.
| Date | Nov 9, 2009 (initiated Aug 28, 2009) |
| Status | Terminated |
| Reason | Thirty-eight lots of Ocufilcon D 55% 1-Day Toric Contact Lens with a modified packaging solution sold under the brand name ClearSight 1-Day Toric were inadvertently shipped into the US market prior to complete evaluation of the 510(k) by the FDA. |
| Root cause | Other |
| Action | Urgent: Medical Device Recall - Contact Lens letters, dated 8/28/09, Response Forms, along with reorder forms and postage paid return labels were sent to the consignees via first class mail with instructions for returning the affected product. Customers are to examine their inventory and customer records to determine if they have any of the affected product. The affected products are to be returned and CooperVision will reimburse for all postage associated with the return and replace the lenses free of charge. Questions should be directed to Bonnie Tsymbal at (800) 341-2020 ext. 3210. |
| Quantity | 1440 cartons |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.