CooperVision Inc.

9 devices in the database

  • Model / Serial
    Exp. date 2017-07-11; Lots: R12497769, R12519016, R12508969, R12496191, R12514162, R12518889, R12483347, R12518980, R12496182, R12496192, R12498168, R12502974, R12496166, R12496196, R12501147, R12508370, R12518890, R12518978.
  • Product Classification
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    USA Distribution
  • Product Description
    Biofinity XR Toric contact lenses 8.7/14.5 - 6PK || Biofinity XR Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses are indicated for the correction of ametropia (myopia or hyperopia) with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -5.75 diopters. The Biofinity (comfilcon A) Soft (Hydrophilic) Contact Lenses have been approved for extended wear for up to 6 nights /7 days of continuous wear. It is recommended that the contact lens wearer first be evaluated on a daily wear schedule. If successful, then a gradual introduction of extended wear can be followed as determined by the prescribing Eye Care Practitioner.
  • Model / Serial
    Lot numbers: 446450034703 (Power -0075075090), 446850021203 (Power -0075125090), 446450034904 (Power -0100075090), 446450031005 (Power  -0125075090), 446450030905 (Power -0125075090), 46450031105 (Power -0125075090), 446850024806 (Power -0150125090), 447050023406 (Power  -0150125180), 447050022408 (Power -0200125180), 446450031509 (Power -0225075090), 447050024509 (Power -0225125180), 446650019310 (Power  -0250075180), 446650020510 (Power -0250075180), 447050022510 (Power -0250125180), 446650019411(Power -0275075180), 446650020611(Power -0275075180), 446650019512 (Power -0300075180), 447050022812(Power -0300125180), 447050022912 (Power -0300125180), 447050022712 (Power -0300125180), 446650019914 (Power -0350075180), 446650021314 (Power -0375075180), 446650019616 (Power -0400075180), 446650020816 (Power -0400075180), 447050023016 (Power -0400125180), 446650020017(Power -0425075180), 447050023117 (Power -0425125180), 447050023218(Power -0450125180), 447050024118 (Power -0450125180), 447050024718 (Power -0450125180), 446650020119 (Power -0475075180), 447050023319(Power -0475125180), 447050024219 (Power -0475125180), 447050021022(Power -0550125180), 447050021122 (Power -0550125180), 447050023522(Power -0550125180), 447050023624 (Power -0600125180), and 446650016926(Power -0650075180).
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    ClearSight(TM) 1-Day (ocufilcon D) Toric 30 daily disposable contact lenses for astigmatism --- Name and Address on Label: CooperVision Hamble, SO31 4RF, UK, and Scottsville, NY 14546 USA --- Each lens is supplied sterile in a blister containing buffered saline solution. The blister is labeled with the base curve, diameter, dioptric power, manufacturing lot number, and expiration date of the lens. ClearSight contact lenses are made from a material containing 55% water and 45% ocufilcon D, a random copolymer of 2-hydroxyethylmethacrylate and methacrylic acid. The lenses have a tint (VAT Blue 6) which is added to make the lens more visible for handling. || When placed on the cornea in its hydrated state, the ClearSight" (ocufilcon D) Soft (Hydrophilic) Contact Lens acts as a refracting medium to focus light rays on the retina.
  • Model / Serial
    Lot 446350083516, potential incorrect expiry date 6/2019; Lot 446450110928, potential incorrect expiry date 2/2019; Lot 446450173709, potential incorrect expiry date 4/2018; Lot 446450191100, potential incorrect expiry date 5/2019; Lot 446550083005, potential incorrect expiry date 5/2019; Lot 446550084607, potential incorrect expiry date 2/2018;  Lot 446650162408, potential incorrect expiry date 2/2018; Lot 446650177200, potential incorrect expiry date 2/2018; Lot 446650178110, potential incorrect expiry date 6/2017; Lot 446650179207, potential incorrect expiry date 6/2018; Lot 446750082713, potential incorrect expiry date 7/2019; Lot 446850029326, potential incorrect expiry date 4/2016; Lot 446850032905, potential incorrect expiry date 4/2016; Lot 446850129305, potential incorrect expiry date 1/2019; Lot 446850132713, potential incorrect expiry date 3/2019; Lot 446850133506, potential incorrect expiry date 6/2018; Lot 447050177419, potential incorrect expiry date 2/2018;  Lot 447050181906, potential incorrect expiry date 1/2017;  Lot 447050206016, potential incorrect expiry date 11/2019.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Aruba, Canada, Colombia and Trinidad.
  • Product Description
    ClearSight(TM) Toric 1 day (ocufilcon D), 30 daily disposable contact lenses for astigmatism, STERILE, Rx only --- CooperVision Hamble, SO31 4RF, UK - Scottsville, NY 14546 USA - Juana Diaz, PR 00795 USA || daily use disposable contact lenses for astigmatism
  • Model / Serial
    Lot 361950571720, potential incorrect expiry date 1/2018;  Lot 361950575934, potential incorrect expiry date 9/2017;  Lot 361950589008, potential incorrect expiry date 2/2018;  Lot 361950590915, potential incorrect expiry date 8/2018; Lot 361950597210, potential incorrect expiry date 7/2017; Lot 361950599011, potential incorrect expiry date 8/2018; Lot 361950599816, potential incorrect expiry date 9/2017; Lot 361950606714, potential incorrect expiry date 12/2017;  Lot 361950608721, potential incorrect expiry date 6/2018;  Lot 361950613813, potential incorrect expiry date 1/2018; Lot 361950632507, potential incorrect expiry date 3/2018; Lot 361950638202, potential incorrect expiry date 2/2017; Lot 361950644719, potential incorrect expiry date 10/2018; Lot 361950646326, potential incorrect expiry date 10/2018; Lot 361950647128, potential incorrect expiry date 10/2018;  Lot 361950676608, potential incorrect expiry date 12/2018; Lot 361950682615, potential incorrect expiry date 10/2017; Lot 361950684220, potential incorrect expiry date 10/2019; Lot 361950691505, potential incorrect expiry date 1/2017; Lot 361950692806, potential incorrect expiry date 7/2018; Lot 361950706108, potential incorrect expiry date 12/2018; Lot 361950706308, potential incorrect expiry date 1/2015; Lot 361950711903, potential incorrect expiry date 7/2018; Lot 361950712707, potential incorrect expiry date 2/2017; Lot 361950742714, potential incorrect expiry date 1/2017; Lot 361950744516, potential incorrect expiry date 10/2017; Lot 361950767118, potential incorrect expiry date 4/2018; Lot 361950778620, potential incorrect expiry date 1/2018; Lot 361950789608, potential incorrect expiry date 4/2018; Lot 361950800811, potential incorrect expiry date 3/2017; Lot 361950826215, potential incorrect expiry date 3/2018; Lot 361950829333, potential incorrect expiry date 9/2017; Lot 361950839008, potential incorrect expiry date 4/2017; Lot 361950845916, potential incorrect expiry date 3/2018; Lot 361950859017, potential incorrect expiry date 3/2017; Lot 361950863106, potential incorrect expiry date 9/2017; Lot 361950894913, potential incorrect expiry date 1/2018; Lot 361950912828, potential incorrect expiry date 6/2018; Lot 361950919611, potential incorrect expiry date 4/2018; Lot 361950919914, potential incorrect expiry date 4/2018; Lot 361950937619, potential incorrect expiry date 5/2018; Lot 361950955510, potential incorrect expiry date 7/2013, 8/2018; Lot 361950955610, potential incorrect expiry date 3/2018;  Lot 361950971611, potential incorrect expiry date 4/2018; Lot 361950972311, potential incorrect expiry date 8/2018, 8/2013; Lot 361951007612, potential incorrect expiry date 7/2017;  Lot 361951028930, potential incorrect expiry date 2/2018; Lot 361951041224, potential incorrect expiry date 2/2018; Lot 361951053705, potential incorrect expiry date 7/2018; Lot 361951057108, potential incorrect expiry date 7/2018.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Aruba, Canada, Colombia and Trinidad.
  • Product Description
    Pro clear(R) 1 day Sphere (o mafilcon A), 90 daily disposable contact lenses, STERILE, Rx ONLY --- Coopervision Shamble, SO 31 4 RF, UK - Scottsville, NY 14546 USA - Juana Diaz, PR 00795 USA || daily use disposable contact lenses
  • Model / Serial
    Affected Packaging Lot Numbers: 10437500002006 10440550000010 10444500007006 10445500007010 10445550003002 10437500004002 10440550000016 10444500008002 10445500007014 10445550003004 10437500005016 10440550001004 10444500008006 10445500007016 10445550003005 10437500006010 10441500003002 10444500009004 10445500007018 10445550003007 10437500006016 10441500004002 10444500009006 10445500007020 10445550003009 10437500006018 10441500004008 10444500010004 10445500007022 10445550003010 10437500007004 10441550000006 10444500010006 10445500007024 10445550003014 10437500007012 10441550001008 10444500011004 10445500008000 10445550003016 10437500007014 10442500002016 10444500011006 10445500008002 10445550004004 10437500007016 10442500003008 10444550001003 10445500008004 10445550004005 10437500007020 10442500004002 10444550001006 10445500008006 10445550004010 10437500008014 10442500004014 10444550001007 10445500008008 10445550004014 10437550000004 10442500005008 10444550001010 10445500008010 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10561500018010 10562500019008 10546500010002 10555500016002 10561500018024 10562500019012 10546500010008 10555550003012 10561550003012 10562500019016 10546500010016 10555550004016 10561550007020 10562500019018 10546500010018 10556500009012 10562500005013 10562500020008 10546500011024 10556500009014 10562500006013 10562500020016 10546500012006 10556500010008 10562500009020 10562500020018 10546500014016 10556500010022 10562500010020 10562500021002 10547500010008 10557500013002 10562500011022 10562500021008 10547500012002 10557550003012 10562500012000 10562500021012 10547500012022 10558550002022 10562500012020 10562500022002 10547500013012 10559500007018 10562500012022 10562500022012 10547500014024 10559500010008 10562500013014 10562500023002 10548500008006 10559500011010 10562500013016 10562500023008 10548500008016 10559500012000 10562500013022 10562500023012 10548500011000 10560500009008 10562500013024 10562500024002 10549500010024 10560500010022 10562500014000 10562500024012 10549500012002 10560500011014 10562500014010 10562550000009 10549500013014 10560500013014 10562500014014 10562550006006 10549550003008 10560500013024 10562500014016 10562550006016 10550500011016 10560500014002 10562500014018 10562550008010 10550500011024 10560500014020 10562500014020 10562550008014 10551500012006 10560500015016 10562500014024 10562550008016 10551500012016 10560500016020 10562500015000 10562550009006 10551500012020 10560550004016 10562500015004 10562550009024 10551500013014 10561500004015 10562500015010 10551550000003 10561500005018 10562500015014 10552500010002 10561500007018 10562500015016 10552500011008 10561500009008 10562500015020 10552500013002 10561500009016 10562500015022 10552500013006 10561500009018 10562500015024 10552500015006 10561500010008 10562500016000 10552550002010 10561500011008 10562500016006 10552550003010 10561500011014 10562500016008. --- 10/12/11 EXPANSION - Addtional Affected Packaging Lot Numbers: 10439550000002, 10462500003002, 10488500004002,  10445500012000, 10443500003004, 10462500005002, 10482500003003, 10452500004016, 10443500006006, 10464500004002, 10490550002004,  10452500007014, 10448500003006, 10464500005002, 10452500008006, 10452500006010, 10466500003003, 10490500007004, 10454500004023, 10456500005004, 10476500005008, 10454500005001, 10453500012010, 10472500007004, 10481550002008, 10454500006000, 10447550000014, 10461500005006, 10454500008019, 10454500012018, 10462550000006, 10454500011014, 10447550000020, 10464500008006, 10489500001010, 10454500013018, 10454500014022, 10471500001006, 10454500017010,  10462500006000, 10471500009010, 10454550004009, 10463500005000, 10455500009012, 10490500007010, 10454550006016, 10463500007000, 10463500007014, 10454550007007, 10464550002000, 10462500004020, 10490500010016, 10454550008008, 10472500010020, 10482500003002, 10482500006020, 10490550003023, 10472500007000, 10490500013022, 10535500017016.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) including Puerto Rico and the countries of: Australia, Canada, Europe, Germany, Hong Kong, Italy, New Zealand, and Spain.
  • Product Description
    AVAIRA Toric (enfilcon A) TORIC soft (Hydrophilic) Contact Lenses, 6 SOFT CONTACT LENSES FOR ASTIGMATISM, CooperVision, Scottsville, NY 14546 USA; Juana Diaz, PR 00795 USA; Hamble SO31, 4RF, UK; Device Listing # D033736. || Product Usage: Indicated for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00- to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters. The AVAIRA Soft Contact Lens is indicated for single - use disposable wear and daily wear. When prescribed for frequent replacement, the lens may be disinfected using a chemical or hydrogen peroxide disinfecting system.
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3 manufacturers with a similar name

Learn more about the data here

  • Manufacturer Address
    Coopervision Inc., 370 Woodcliff Dr Ste 200, Fairport NY 14450-4237
  • Manufacturer Parent Company (2017)
  • Source
    USFDA