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U.S. Department of Health and Human Services

Class 3 Device Recall Encore and OneVue

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 Class 3 Device Recall Encore and OneVuesee related information
Date Initiated by FirmJune 25, 2003
Date PostedJuly 03, 2003
Recall Status1 Terminated 3 on April 11, 2005
Recall NumberZ-0978-03
Recall Event ID 26532
510(K)NumberK973063 
PMA NumberP850079 
Product Classification Lenses, Soft Contact, Daily Wear - Product Code LPL
ProductSOFT 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.
Code Information There are 768 lot numbers as follows: 3669001157,  3669001465,  3669001756,  3669001960,  3669002711,  3669002714,  3669002816,  3669003208,  3669003214,  3669500011,  3669500414,  3669500514,  3779000756,  3779001722,  3779002117,  3779002513,  3779002911,  3779003020,  3779003624,  3779003906,  3779005316,  3779500013,  3779500120,  3890000722,  3890001706,  3891001712,  3892000954,  3892001402,  3892001414,  3892001712,  3893001417,  3893001611,  3893001711,  3893002612,  3893002613,  3893002712,  3893003020,  3893003107,  3893003302,  3893003614,  3893004706,  3893004806,  3893500111,  3893500702,  3893500802,  3893500902,  3894001058,  3894001560,  3894001654,  3894002213,  3894002607,  3894002610,  3894002811,  3894003005,  3894004306,  3894004502,  3894004904,  3894005004,  3894500205,  3894500310,  3894500311,  3894500313, 3894500402,  3894500411,  3894500511,  3894500704,  3894500706,  3895001456, 3895002758,  3895002855,  3895003024,  3895003220,  3895003315, 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Recalling Firm/
Manufacturer
Coopervision Inc
711 North Road
Scottsville NY 14643
For Additional Information ContactBonnie Tsymbal
585-264-3210
Manufacturer Reason
for Recall
The actual sphere power of the lens is lower than the labeled value.
FDA Determined
Cause 2
Other
ActionLetters 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 in Commerce23,762 6-packs / 76,748 singles (trial lenses)
DistributionCoopervision, Scottsville, NY is recalling from domestic customers nationwide. Product in Canada and Europe being recalled by affiliate in Europe.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = LPL
PMA DatabasePMAs with Product Code = LPL
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