Recall Z-0134-2015 ยท LPL Lenses, Soft Contact, Daily Wear
Cooper Vision Caribbean Corp.
ProClear Toric contact lenses are made from a material containing 62% water and 38% omafilcon B, a random copolymer of 2-hydroxyethylmethacrylate and methacrylic acid. The lenses have a tint (VAT Blue 6) which is added to make the lens more visible for handling.
| Date | Oct 24, 2014 (initiated Sep 17, 2014) |
| Status | Terminated |
| Reason | Routine quality monitoring system has identified that a limited number of lots were manufactured with the cylinder axis outside the allowable specification. |
| Root cause | Other |
| Action | The firm sent out a notification letter with the following instructions: Please take the following actions immediately: " Examine your inventory for any affected lot numbers o Use the enclosed report to inspect your inventory for affected product that is still in your Warehouse. " Stop any further distribution of the specified lots of Preclear T oric lenses. " Quarantine any Preclear Toric lenses with the specified lot numbers. " Within the next five (5) business days, please complete the attached Recall Response Form and fax it to 866-484-1048 or scan and email to info@coopervision.com. o If |
| Quantity | 13639 lenses/246 product lots |
| Distribution | Worldwide Distribution: US (nationwide) and internationally to: Canada, Latin America, EU, Asia Pacific, and Africa/Central Eurasia countries. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123202 | PROCLEAR (OMAFILCON A) SOFT HYDROPHILIC) CONTACT LENS CooperVision, Inc., May 30, 2013 |