Recall Z-0978-03 ยท LPL Lenses, Soft Contact, Daily Wear
Coopervision Inc
SOFT CONTACT LENSES (toric) packaged under the following labels: (1) CV \ ENCORE toric (methafilcon A) and (2) ONEVUE 55 toric (methafilcon A) flexible wear. Responsible firm on label: Coopervision, Hamble, SO31, 4RF, UK, Scottsville, NY 14546, USA *** Made in UK. The lenses are sold in boxes of 6 and sold individually as trial lenses.
| Date | Jul 3, 2003 (initiated Jun 25, 2003) |
| Status | Terminated |
| Reason | The actual sphere power of the lens is lower than the labeled value. |
| Root cause | Other |
| Action | Letters dated June 24, 2003 issued to eye care practitioners and distributors with instructions to return lenses to Coopervision. Distributors also instructed to notify their customers. |
| Quantity | 23,762 6-packs / 76,748 singles (trial lenses) |
| Distribution | Coopervision, Scottsville, NY is recalling from domestic customers nationwide. Product in Canada and Europe being recalled by affiliate in Europe. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K973063 | FREQUENCY 55 (METHAFILCON A) HYDROPHILIC CONTACT LENS FOR DAILY WEAR Aspect Vision Care, Ltd., Aug 26, 1997 |