Z-0978-03

SOFT CONTACT LENSES (toric) packaged under the following labels: (1) CV \ ENCORE toric (methafilcon A) and...

Name: Z-0978-03 SOFT CONTACT LENSES (toric) packaged under the following labels: (1) CV \ ENCORE toric (methafilcon A) and...
Creator: Coopervision Inc
Published: 2003-06-25
License: https://open.fda.gov/license/

CooperVision, Inc. / initiated 2003-06-25 / Terminated / root cause: labeling and UDI

FDA source

Coopervision Inc began a recall of SOFT CONTACT LENSES (toric) packaged under the following labels: (1) CV \ ENCORE toric (methafilcon A) and (2) ONEVUE 55 toric (methafilcon A) flexible wear... on 2003-06-25. The reason FDA records is "The actual sphere power of the lens is lower than the labeled value". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0978-03
Status: Terminated
Initiated: 2003-06-25
Posted: 2003-07-03
Terminated: 2005-04-11
Recalling firm: CooperVision, Inc.
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.
Product code: LPL Lenses, Soft Contact, Daily Wear
Reason for recall: The actual sphere power of the lens is lower than the labeled value.
Root cause tag: labeling and UDI
FDA root 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.
Product codes and lots: 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, 3904500213, 3904500305, 3905001157, 3905001257, 3905001665, 3905001852, 3905002026, 3905002056, 3905003321, 3905004115, 3905004260, 3905004455, 3905004505, 3905004615, 3905004705, 3905004911, 3905004914, 3905005011, 3905005014, 3905005111, 3905005114, 3905005124, 3905005602, 3905005702, 3905005724, 3905005802, 3905006316, 3905006416, 3905007506, 3905007812, 3905500017, 3905500105, 3905500117, 3905500210, 3905500410, 3905500411, 3905500414, 3905500515, 3905500607, 3905500616, 3905500708, 3905500716, 3905500720, 3905501004, 3906001552, 3906002614, 3906002714, 3907001260, 3907003006, 3907003511, 3907003607, 3907003614, 3907003714, 3907003716, 3907003816, 3907004112, 3907004308, 3907004424, 3907004524, 3907005410, 3907005710, 3907500011, 3907500210, 3907500324, 3911001411, 3912001262, 3912001265, 3912001905, 3912002224, 3912003400, 3912003611, 3912004007, 3912004107, 3912004207, 3912500011, 3912500107, 3913001255, 3913001460, 3913001462, 3913002205, 3913002814, 3913002910, 3913003010, 3913003110, 3913500105, 3913500205, 3913500308, 3914001462, 3914001923, 3914002155, 3914002165, 3914002255, 3914003160, 3914003311, 3914003322, 3914003411, 3914004513, 3914004524, 3914004613, 3914004624, 3914004907, 3914005007, 3914005116, 3914005205, 3914005305, 3914005405, 3914005505, 3914005605, 3914006614, 3914006702, 3914006703, 3914006902, 3914007408, 3914007508, 3914007508, 3914500011, 3914500105, 3914500111, 3914500205, 3914500308, 3914500313, 3914500413, 3914500903, 3915000862, 3915001060, 3915001265, 3915001453, 3915001455, 3915001654, 3915002605, 3915500065, 3915500205, 3916000851, 3916002513, 3916002602, 3916002702, 3916005504, 3916500204, 3921001051, 3921003118, 3921003218, 3921004000, 3921004024, 3921004124, 3921004212, 3921004224, 3921004312, 3921004414, 3921004606, 3921005220, 3921005311, 3921500212, 3921500224, 3921500312, 3921500314, 3921500324, 3921500412, 3921500512, 3922000926, 3922000960, 3922001907, 3922002017, 3922002052, 3922002224, 3922002508, 3922003416, 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, 4332002224, 4332003611, 4332004107, 4333001360, 4333002814, 4333002910, 4333003010, 4333500160, 4334002155, 4334002165, 4334003160, 4334003311, 4334004524, 4334006614, 4334006902, 4334007408, 4334007508, 4334500124, 4334500224, 4335001060, 4335001265, 4335001355, 4336002513, 4336002602, 4341004024, 4341004212, 4341004414, 4341005220, 4342002508, 4342003416, 4342500106, 4343002160, 4343002511, 4343006602, 4343006813, 4343007007, 4343007107, 4343007914, 4343008014, 4343008306, 4343008406, 4343008512, 4343008612, 4343008710, 4343008920, 4343009010, 4343010916, 4343500007, 4343500160, 4343500320, 4344002109, 4344004100, 4344500265, 4344500304, 4344500355, 4344500365, 4344500455, 4344500465, 4345002513, 4345003120, 4350001060, 4350002409, 4350002712, 4351002206, 4351500060, 4351500106, 4351500112, 4351500160, 4351500212, 4352001060, 4352003708, 4352003808, 4352003912, 4352004012, 4352006500, 4352006600, 4352006700, 4352500008, 4352500160, 4353002220, 4353002706, 4353003000, 4353003200, 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,

Product code LPL

K973063Class IIFrequency 55 (Methafilcon a) Hydrophilic Contact Lens for Daily WearAspect Vision Care, Ltd. / cleared 1997-08-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)