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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 OneVue see related information
Date Initiated by Firm June 25, 2003
Date Posted July 03, 2003
Recall Status1 Terminated 3 on April 11, 2005
Recall Number Z-0978-03
Recall Event ID 26532
510(K)Number K973063  
PMA Number P850079 
Product Classification Lenses, Soft Contact, Daily Wear - Product Code LPL
Product 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.
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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 3923500914,  3923501006,  3923501010,  3923501014,  3923501106,  3923501110,  3923501210,  3923501312,  3923501416,  3923501516,  3924001051,  3924001154,  3924001455,  3924001558,  3924002304,  3924004100,  3924500208,  3925002100,  3925002107,  3925002513,  3925002624,  3925003120,  3925003416,  3925004011,  3925004510,  3925500116,  3927000865,  3930001205,  3930001305,  3930002409,  3930002712,  3931002206,  3931002812,  3932002118,  3932002801,  3932003205,  3932003305,  3932003708,  3932004116,  3932006700,  3932500016,  3932500105,  3932500201,  3932500212,  3932500400,  3932500500,  3933000564,  3933001405,  3933002220,  3933002706,  3933500005,  3933500300,  3933500400,  3934000805,  3934002706,  3934002904,  3934003012,  3939002914,  3939003106,  3939003812,  3939004120,  3940000957,  3940001152,  3940001909,  3940002305,  3940002410,  3940002914,  3940003908,  3940500108,  3940500114,  3941002258,  3941002452,  3941002651,  3941002665,  3941002955,  3941003518,  3941003719, 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Recalling Firm/
Manufacturer		 Coopervision Inc
711 North Road
Scottsville NY 14643
For Additional Information Contact Bonnie 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
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 in Commerce 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.
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 = ASPECT VISION CARE, LTD.
PMA Database PMAs with Product Code = LPL and Original Applicant = COOPERVISION, INC.
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