Recall Z-1091-03 ยท LPL Lenses, Soft Contact, Daily Wear
Coopervision Inc
Frequency 55 Toric (methafilcon B), flexible wear contact lenses (tinted). Responsible firms on the label: CooperVision ** Hamble, SO31 4RF, UK ** Scottsville, NY 14546.
| Date | Aug 7, 2003 (initiated Jul 22, 2003) |
| Status | Terminated |
| Reason | Mislabeled with incorrect sphere power. |
| Root cause | Other |
| Action | Customers notified via telephone on 7/22/03. |
| Quantity | 152 lenses |
| Distribution | Nationwide. 33 eye care practitioners in the following states: AR, AL, CA, DE, FL, GA, IA, KS, MI, MA, NJ, NY, NC, OH, OK, PA, TX, UT, VA, and WI. Lenses were also shipped to Coopervision affiliates in the United Kingdom and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K962185 | HYDRASOFT (EAST) AND HYDRASOFT TORIC(EAST) (METHAFILCON B) DAILY WEAR SOFT HYDROPHILIC CONTACT LENS CooperVision, Inc., Dec 17, 1996 |