Class 3 Device Recall Frequency 55

• Date Initiated by Firm: July 22, 2003
• Date Posted: August 07, 2003
• Recall Status: Terminated on February 13, 2004
• Recall Number: Z-1091-03
• Recall Event ID: 26795
• 510(K)Number: K962185
• PMA Number: P850079
• Product Classification: Lenses, Soft Contact, Daily Wear - Product Code LPL
• Product: Frequency 55 Toric (methafilcon B), flexible wear contact lenses (tinted). Responsible firms on the label: CooperVision ** Hamble, SO31 4RF, UK ** Scottsville, NY 14546.
• Code Information: 1468-212, Exp. 10/2008
• Recalling Firm/ Manufacturer: Coopervision Inc; 711 North Road; Scottsville NY 14643
• For Additional Information Contact: Bonnie Tsymbal; 585-264-3210
• Manufacturer Reason for Recall: Mislabeled with incorrect sphere power.
• FDA Determined Cause: Other
• Action: Customers notified via telephone on 7/22/03.
• Quantity in Commerce: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = LPL
• PMA Database: PMAs with Product Code = LPL