Class 3 Device Recall Encore and OneVue

• Date Initiated by Firm: June 25, 2003
• Date Posted: July 03, 2003
• Recall Status: Terminated 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, 3895003320, 3895003514, 3895003614, 3895003660, 3895004312, 3895004512, 3895004807, 3895004907, 3895005210, 3895005403, 3895005904, 3895006004, 3895006305, 3895006405, 3895006406, 3895006505, 3895006808, 3895500112, 3895500114, 3895500212, 3895500214, 3895500360, 3895500607, 3895500608, 3895500656, 3895500708, 3895500805, 3895500806, 3895500808, 3895500906, 3895501006, 3895501104, 3895501106, 3895501206, 3895501306, 3896001066, 3896001256, 3896001458, 3896001751, 3896001912, 3896002309, 3896002903, 3896003300, 3896003400, 3896003500, 3896500112, 3896500200, 3896500403, 3897000656, 3897002209, 3897002224, 3897002506, 3897002808, 3897002814, 3897002820, 3897003904, 3897500008, 3897500106, 3898000756, 3901001610, 3903000757, 3903000857, 3903001051, 3903002411, 3903002602, 3903002814, 3903003707, 3903003713, 3903003807, 3903500007, 3903500107, 3903500214, 3903500311, 3904000402, 3904000561, 3904000657, 3904001251, 3904001356, 3904001717, 3904002060, 3904002313, 3904003018, 3904003102, 3904003202, 3904003204, 3904500002, 3904500103, 3904500203, 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3922004016, 3922500306, 3922500316, 3922500424, 3923000857, 3923001960, 3923002155, 3923002360, 3923002551, 3923003152, 3923004517, 3923004617, 3923004717, 3923005005, 3923005105, 3923006602, 3923006613, 3923006813, 3923007307, 3923007322, 3923007407, 3923007422, 3923007914, 3923008014, 3923008108, 3923008114, 3923008208, 3923008308, 3923008406, 3923008412, 3923008506, 3923008610, 3923008612, 3923008920, 3923009010, 3923009210, 3923011016, 3923011216, 3923011316, 3923500151, 3923500152, 3923500311, 3923500317, 3923500407, 3923500417, 3923500505, 3923500507, 3923500513, 3923500517, 3923500622, 3923500705, 3923500722, 3923500805, 3923500906, 3923500910, 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, 3941003722, 3941004824, 3941004920, 3941004924, 3941005009, 3941005020, 3941005109, 3941005220, 3941005710, 3941005712, 3941005804, 3941005812, 3941005904, 3941006004, 3941006010, 3941006106, 3941006108, 3941006610, 3941006700, 3941007000, 3941500216, 3941500322, 3941500410, 3941500508, 3941500510, 3941500511, 3941500520, 3941500524, 3941500608, 3941500620, 3941500708, 4308001960, 4308002711, 4308002816, 4308003214, 4308500114, 4308500214, 4309002513, 4309003624, 4314001611, 4314002612, 4314003020, 4314003202, 4314003614, 4314004706, 4314500006, 4314500220, 4315001560, 4315002213, 4315002611, 4315004306, 4315500102, 4315500210, 4315500310, 4316002855, 4316003024, 4316003124, 4316003220, 4316003314, 4316003320, 4316003414, 4316004312, 4316004412, 4316004807, 4316004907, 4316005904, 4316006306, 4316006408, 4316006506, 4316006608, 4316500014, 4316500108, 4316500204, 4316500306, 4317001912, 4317002309, 4317003200, 4317500160, 4318002109, 4318002209, 4318002224, 4318002820, 4318500014, 4323002411, 4324000402, 4324001560, 4324003102, 4324500260, 4325004255, 4325004260, 4325004911, 4325004914, 4325005107, 4325005114, 4325005124, 4325005702, 4325005802, 4325006216, 4325006316, 4325006810, 4325006910, 4325006920, 4325007108, 4325007208, 4325007812, 4325500107, 4325500111, 4325500124, 4325500255, 4325500360, 4326000960, 4326002508, 4326002614, 4326002714, 4327001260, 4327004424, 4327005410, 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4353500160, 4354003012, 4360001155, 4360002814, 4360002914, 4360003808, 4360500108, 4360500109, 4360500110, 4361002665, 4361004724, 4361004824, 4361004920, 4361005024, 4361005109, 4361005216, 4361005712, 4361005804, 4361005911, 4361006008, 4361006010, 4361006210, 4361006510, 4361006700, 4361006800, 4361500009, 4361500016, 4361500120, 4361500300, 4361500365, 4361500455, 4361500555, 6591001465, 6591001960, 6598002213, 6598002611, 6599002855, 6599003315, 6599003414, 6599004312, 6599005904, 6608004355, 6608004911, 6608005602, 6608007108, 6609000960, 6616001460, 6616002205, 6616002910, 6617002155, 6617003411, 6617007408, 6617500005, 6617500005, 6618001355, 6626001960, 6626005005, 6626008920, 6626010916, 6627001455, 6627004100, 6627500065, 6634001805, 6634001905, 6635003205, 6635003708, 6635006600, 6636001255, 6636003000, 6636003200, 6636500006, 6636500006, 6643001155, 6643001265, 6643002814, 6644002665, 6644002955, 6644004724, 6644005020, 6644005712, 6644005712, 6644005804, 6644006110, 6644006700, 9198000601, 9198000613, 9198000712, 9198000812, 9199000713, 9201000313, 9215001213, 9215001712, 9215001812, 9215001912, 9215002012, 9801001851, 9804001706, 9807003614, 9809003320, 9811002224, 9814001610, 9818001157, 9818001864, 9820004524, 9825004007, 9838003516, 9843002409, 9844001905, 9853002305,
• 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: 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
• PMA Database: PMAs with Product Code = LPL