CooperVision Inc.

Exp. date 2017-07-11; Lots: R12497769, R12519016, R12508969, R12496191, R12514162, R12518889, R12483347, R12518980, R12496182, R12496192, R12498168, R12502974, R12496166, R12496196, R12501147, R12508370, R12518890, R12518978.

Ophthalmic Devices

3

No

USA Distribution

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.

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).

Ophthalmic Devices

2

No

Nationwide Distribution

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.

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.

Ophthalmic Devices

2

No

Worldwide Distribution - USA (nationwide) and the countries of Aruba, Canada, Colombia and Trinidad.

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

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.

Ophthalmic Devices

2

No

Worldwide Distribution - USA (nationwide) and the countries of Aruba, Canada, Colombia and Trinidad.

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

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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10443550000012 10445500005013 10445500012012 10446500007002 10439500004020 10443550001004 10445500006000 10445500013012 10446500007004 10439500005006 10444500003002 10445500006002 10445500015006 10446500007006 10439500005008 10444500004002 10445500006003 10445500016006 10446500007008 10439550000004 10444500004003 10445500006004 10445500017006 10446500007016 10439550000006 10444500004016 10445500006008 10445500018006 10446500008004 10439550000009 10444500004018 10445500006009 10445550000018 10446500008005 10439550000016 10444500005002 10445500006010 10445550001001 10446500008006 10439550000020 10444500005008 10445500006012 10445550001012 10446500009004 10439550001012 10444500005014 10445500006015 10445550001022 10446500009005 10440500003002 10444500006002 10445500007000 10445550002001 10446500009006 10440500004002 10444500006007 10445500007002 10445550002004 10446500009012 10440500004014 10444500006008 10445500007003 10445550002011 10446500010006 10440500005018 10444500007002 10445500007004 10445550002016 10446500010012 10440550000002 10444500007004 10445500007008 10445550002024 10446500011012 10446550000003 10449500005004 10453500005007 10453550001004 10454500009014 10446550000012 10449550000008 10453500005013 10453550001011 10454500009018 10446550000020 10450500004020 10453500006000 10453550001014 10454500009020 10446550001002 10450500006008 10453500006006 10453550002004 10454500009022 10446550001004 10450550000012 10453500006008 10453550002006 10454500010002 10446550001008 10450550000014 10453500006013 10453550002007 10454500010006 10446550001008 10450550001006 10453500006019 10453550002008 10454500010008 10446550001009 10450550002006 10453500007004 10453550002010 10454500010013 10446550001013 10451500004018 10453500007005 10453550002016 10454500010014 10446550002004 10451500004022 10453500007006 10453550003006 10454500010015 10446550002006 10451500005012 10453500007008 10453550003008 10454500010018 10446550002010 10451500005020 10453500007012 10453550003010 10454500010020 10447500003002 10451500006020 10453500007016 10453550004008 10454500010022 10447500004002 10451550000016 10453500007022 10453550004012 10454500011002 10447500004004 10451550001010 10453500008004 10454500001000 10454500011006 10447500004008 10452500002016 10453500008005 10454500002000 10454500011008 10447500004022 10452500004000 10453500008006 10454500003000 10454500011010 10447500005004 10452500004001 10453500008008 10454500004000 10454500011013 10447500005006 10452500004002 10453500008010 10454500005000 10454500011015 10447500005008 10452500005006 10453500008012 10454500005004 10454500011018 10447500005010 10452500005010 10453500008016 10454500005007 10454500011020 10447500005012 10452500006006 10453500008022 10454500005011 10454500011022 10447500006004 10452500006014 10453500009004 10454500005019 10454500012006 10447500006006 10452500006018 10453500009005 10454500006002 10454500012008 10447500006008 10452500007006 10453500009006 10454500006004 10454500012010 10447500006010 10452500007008 10453500009008 10454500006008 10454500012013 10447500007006 10452500007010 10453500009012 10454500006014 10454500012020 10447500008006 10452500007012 10453500009016 10454500006019 10454500012022 10447500008012 10452500008008 10453500009018 10454500006021 10454500013006 10447500009006 10452500008010 10453500009020 10454500007002 10454500013008 10447500009012 10452500008012 10453500009022 10454500007003 10454500013010 10447550000002 10452500009008 10453500010004 10454500007004 10454500013012 10447550000010 10452500009012 10453500010005 10454500007005 10454500013016 10447550000018 10452550000008 10453500010008 10454500007008 10454500013022 10447550001002 10452550000018 10453500010012 10454500007013 10454500014006 10448500002000 10452550001010 10453500010016 10454500007018 10454500014008 10448500002016 10452550001014 10453500010018 10454500007019 10454500014010 10448500003002 10452550001016 10453500010020 10454500007021 10454500014012 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10463550008004 10454550006018 10455550004008 10461500004004 10463500002000 10464500002018 10454550006020 10456500001000 10461500004008 10463500003004 10464500003004 10454550006024 10456500002016 10461500005002 10463500004004 10464500003014 10454550007008 10456500003002 10461500005004 10463500005004 10464500003018 10454550007020 10456500003008 10461500005008 10463500005005 10464500004000 10454550007024 10456500003014 10461500006002 10463500005008 10464500004004 10455500001008 10456500004004 10461500006004 10463500005009 10464500005004 10455500002008 10456500004008 10461500007004 10463500006002 10464500005008 10455500002018 10456500004014 10461500007006 10463500006004 10464500005010 10455500003002 10456500005014 10461500008006 10463500006008 10464500005012 10455500003008 10456500005018 10461550000000 10463500006009 10464500006010 10455500003010 10456500006006 10461550000003 10463500006012 10464500006012 10455500003018 10456500006010 10461550000010 10463500006022 10464500007002 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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.

Ophthalmic Devices

2

No

Worldwide Distribution - USA (nationwide) including Puerto Rico and the countries of: Australia, Canada, Europe, Germany, Hong Kong, Italy, New Zealand, and Spain.

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.