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U.S. Department of Health and Human Services

Class 3 Device Recall Frequency 55

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  Class 3 Device Recall Frequency 55 see related information
Date Initiated by Firm July 22, 2003
Date Posted August 07, 2003
Recall Status1 Terminated 3 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 2		 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 and Original Applicant = COOPERVISION, INC.
PMA Database PMAs with Product Code = LPL and Original Applicant = COOPERVISION, INC.
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