Devices

Device Recall AVAIRA

  • 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 10445550005004 10437550000008 10442500006008 10444550001018 10445500008014 10445550005005 10437550001016 10442500006012 10444550002002 10445500008016 10445550005006 10437550001024 10442550000004 10444550002004 10445500008022 10445550005010 10437550002000 10442550000016 10444550002006 10445500008024 10446500002009 10437550002006 10442550000018 10444550002008 10445500009000 10446500003007 10437550002016 10442550001010 10444550002010 10445500009002 10446500003010 10437550002018 10443500001014 10444550002018 10445500009004 10446500003022 10437550003006 10443500004004 10444550003004 10445500009006 10446500004002 10437550004006 10443500005002 10444550003006 10445500009008 10446500004004 10437550004012 10443500005004 10444550003008 10445500009010 10446500004006 10438500004018 10443500005012 10444550004000 10445500009016 10446500004007 10438500005014 10443500005019 10445500003000 10445500010000 10446500004008 10438500005016 10443500006002 10445500003001 10445500010002 10446500004010 10438500006014 10443500006004 10445500003002 10445500010004 10446500005002 10438500007008 10443500006012 10445500003007 10445500010006 10446500005004 10438500007012 10443500007002 10445500003011 10445500010008 10446500005006 10438500007016 10443500007004 10445500004002 10445500010010 10446500005008 10438500007020 10443500008006 10445500004004 10445500010012 10446500005016 10438500008016 10443500008010 10445500004007 10445500011000 10446500006000 10438550000004 10443500009006 10445500004008 10445500011002 10446500006002 10438550000016 10443500009008 10445500005000 10445500011006 10446500006003 10438550002006 10443500009010 10445500005002 10445500011008 10446500006004 10439500002018 10443500010006 10445500005003 10445500011012 10446500006006 10439500004000 10443500010008 10445500005004 10445500012002 10446500006008 10439500004002 10443500010010 10445500005005 10445500012006 10446500006016 10439500004004 10443500011006 10445500005008 10445500012008 10446500007000 10439500004010 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 10448500004008 10452550001020 10453500010024 10454500007024 10454500014016 10448500004018 10452550002012 10453500011004 10454500008002 10454500015010 10448500005006 10453500001002 10453500011016 10454500008003 10454500015012 10448500005010 10453500001011 10453500011018 10454500008004 10454500015016 10448500006004 10453500002002 10453500011020 10454500008008 10454500016010 10448500006010 10453500002006 10453500011024 10454500008013 10454500016012 10448500006014 10453500002014 10453500012004 10454500008014 10454500016016 10448500007004 10453500003000 10453500012016 10454500008017 10454500017016 10448550000008 10453500003002 10453500012020 10454500008018 10454500018016 10448550000012 10453500003006 10453500013010 10454500008021 10454500019016 10448550000014 10453500003009 10453500013020 10454500009002 10454550000019 10449500002012 10453500003014 10453500014020 10454500009003 10454550001002 10449500002016 10453500004000 10453500015020 10454500009004 10454550001019 10449500003016 10453500004014 10453550000005 10454500009006 10454550002004 10449500003022 10453500005000 10453550000017 10454500009008 10454550002006 10449500004018 10453500005006 10453550001003 10454500009013 10454550002013 10454550002014 10455500004020 10456550001008 10462500002012 10463500008002 10454550002018 10455500004024 10456550001016 10462500003004 10463500008008 10454550002019 10455500005002 10456550001020 10462500003012 10463500008016 10454550002022 10455500005004 10456550002020 10462500003020 10463500008018 10454550002023 10455500005006 10457500002022 10462500004004 10463500009000 10454550003000 10455500005010 10457500003004 10462500004014 10463500009002 10454550003004 10455500005016 10457500003016 10462500004018 10463500009014 10454550003006 10455500005020 10457500003024 10462500005004 10463500009016 10454550003009 10455500005023 10457500004004 10462500005008 10463500009024 10454550003010 10455500006006 10457500005010 10462500005010 10463500010000 10454550003012 10455500006014 10457550000008 10462500005016 10463500010002 10454550003014 10455500006020 10457550000022 10462500006002 10463500010010 10454550003016 10455500007006 10457550001014 10462500006004 10463500010014 10454550003018 10455500007012 10458500002008 10462500006006 10463500010016 10454550003020 10455500007020 10458500003012 10462500006008 10463500010024 10454550004000 10455500008016 10458500003018 10462500006016 10463500011002 10454550004004 10455500008022 10458500003022 10462500007002 10463500011010 10454550004006 10455500009016 10458500005004 10462500007006 10463500012002 10454550004010 10455500009022 10458550000022 10462500007008 10463500012006 10454550004012 10455500010016 10459500003000 10462500008000 10463500013002 10454550004014 10455550000019 10459500003008 10462500008002 10463500013006 10454550004016 10455550000020 10459500003010 10462500008006 10463500014006 10454550004018 10455550001002 10459500004002 10462500008008 10463500015006 10454550004020 10455550001004 10459500004004 10462500009000 10463500016006 10454550005004 10455550001004 10459500004008 10462500009002 10463500017006 10454550005006 10455550001010 10459500004010 10462500009006 10463550001001 10454550005007 10455550001014 10459500005002 10462500010000 10463550001006 10454550005011 10455550001015 10459500006012 10462500010006 10463550001008 10454550005012 10455550001016 10459550002014 10462500011006 10463550001018 10454550005014 10455550001020 10460500003004 10462550000010 10463550003000 10454550005016 10455550002010 10460500006018 10462550000022 10463550003010 10454550005018 10455550002013 10460550000004 10462550001000 10463550004004 10454550005020 10455550002014 10460550000006 10462550001005 10463550004010 10454550006006 10455550002018 10460550001010 10462550001008 10463550005004 10454550006007 10455550003008 10461500002014 10462550002003 10463550006004 10454550006008 10455550003012 10461500003008 10462550002004 10463550007004 10454550006011 10455550003014 10461500004002 10462550002008 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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10470500006022 10471500009004 10472500006022 10472500011014 10465500003012 10470500007006 10471500009006 10472500007002 10472500011020 10465500004004 10470500007010 10471500009008 10472500007003 10472500011024 10465500004010 10470500007014 10471500009012 10472500007010 10472500012006 10465500004014 10470500007022 10471500009013 10472500007012 10472500012008 10465500005018 10470500008006 10471500009014 10472500007013 10472500012010 10465550000000 10470500008010 10471500009016 10472500007014 10472500012012 10465550000010 10470500010016 10471500009018 10472500007015 10472500012018 10465550000012 10470500011016 10471500009020 10472500007017 10472500012024 10465550000014 10470500012016 10471500009022 10472500007020 10472500013006 10465550001002 10470550000006 10471500010008 10472500007022 10472500013008 10465550001008 10470550000008 10471500010010 10472500007024 10472500013012 10465550002020 10470550001004 10471500010012 10472500008000 10472500013016 10466500004008 10470550001014 10471500010016 10472500008002 10472500013018 10466500004014 10471500001024 10471500010018 10472500008004 10472500014006 10466550000016 10471500002006 10471500010020 10472500008005 10472500014008 10468500004008 10471500002022 10471500011010 10472500008008 10472500014012 10468500004012 10471500003006 10471500011012 10472500008009 10472500014016 10468500004013 10471500003009 10471500011016 10472500008010 10472500014018 10468500004022 10471500003019 10471500011018 10472500008012 10472500015006 10468500005006 10471500003022 10471500011020 10472500008013 10472500015016 10468500005024 10471500003024 10471500012016 10472500008014 10472500015018 10468500006008 10471500004022 10471500012018 10472500008015 10472500016006 10468550000018 10471500004024 10471500013016 10472500008017 10472500016016 10469500003006 10471500005008 10471550000002 10472500008020 10472500016018 10469500003012 10471500005012 10471550001004 10472500008022 10472500017006 10469500003014 10471500005014 10471550001008 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10472550003004 10470500004010 10471500007012 10471550003010 10472500010000 10472550003007 10470500004014 10471500007013 10471550003014 10472500010004 10472550003008 10470500004020 10471500007018 10471550004010 10472500010006 10472550003016 10470500004024 10471500007022 10472500003004 10472500010008 10472550003018 10470500005008 10471500008002 10472500003021 10472500010010 10472550003019 10472550003024 10473500010016 10480500003016 10483500003020 10489500003024 10472550004004 10473500011016 10480500004018 10483500004012 10489500004006 10472550004008 10473550000009 10480500005000 10483500004016 10489500004008 10472550004009 10473550000020 10480550000014 10483550000006 10489500004012 10472550004014 10473550000024 10480550000020 10484500003006 10489500004014 10472550004016 10473550001010 10480550001000 10484500004000 10489500004016 10472550004018 10473550001012 10480550001010 10484550000008 10489500004018 10472550004022 10473550002000 10481500004004 10485500003000 10489500004022 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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.
  • Product Classification
    Ophthalmic Devices
  • 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.
  • Manufacturer
    CooperVision Inc.
  • 1 Event

Manufacturer

CooperVision Inc.
  • Manufacturer Address
    CooperVision Inc., 180 Thruway Park Dr, W Henrietta NY 14586-9798
  • Manufacturer Parent Company (2017)
    The Cooper Companies, Inc.
  • Source
    USFDA

2 devices with a similar name

Learn more about the data here

Device Recall AVAIRA (enfilcon A) Daily Wear Sphere Contact Lens
  • Model / Serial
    Packaged lot numbers: 10433000002003, 10433000002503, 10433000003040, 10433000004002, 10433000004005, 10433000004504, 10433000004509, 10433000004519, 10433000004522, 10433000005005, 10433000005026, 10433000005028, 10433000005030, 10433000005507, 10433000005513, 10433000005516, 10433000005517, 10433000006005, 10433000006007, 10433000006026, 10433000006028, 10433000006030, 10433000006032, 10433000006040, 10433000006505, 10433000006510, 10433000006511, 10433000006515, 10433000006516, 10433000006517, 10433000007007, 10433000007010, 10433000007028, 10433000007030, 10433000007032, 10433000007038, 10433000007506, 10433000007508, 10433000007509, 10433000007511, 10433000007515, 10433000008004, 10433000008011, 10433000008028, 10433000008030, 10433000008032, 10433000008038, 10433000008506, 10433000008508, 10433000008512, 10433000009026, 10433000009028, 10433000009034, 10433000009036, 10433000009506, 10433000009512, 10433000010008, 10433000010016, 10433000010026, 10433000010034, 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639707084607, 639707087705, 639707091106, 639707091605, 639707091904, 639707092605, 639707092804, 639707093704, 639707095905, 639707098105, 639707099806, 639707106206, 639707108605, 639707115406, 639805000005, 639807006866, 639807010230, 639807012628, 639807026026, 639807033926, 639807044417, 639807045513, 639807046624, 639807046714, 639807048316, 639807054312, 639807054910, 639807056603, 639807063020, 639807063408, 639807064108, 639807079007, 639807084404, 639807090805, 639807091306, 639807094006, 639807095106, 639807097404, 639807097905, 639807105206, 639807108705, 639907026026, 639907039618, 639907042813, 639907046814, 639907062608, 639907063615, 639907063808, 639907090304, 639907093304, 639907105506, 639907110605, 639907111006, 640105000106, 640107002133, 640107005465, 640107008862, 640107009360, 640107010030, 640107010230, 640107012628, 640107012630, 640107013928, 640107017328, 640107019628, 640107026626, 640107033102, 640107033602, 640107034026, 640107034223, 640107037226, 640107038518, 640107039222, 640107040618, 640107041517, 640107042613, 640107042813, 640107043813, 640107044117, 640107044517, 640107045121, 640107045513, 640107046919, 640107047614, 640107048316, 640107049824, 640107050924, 640107054509, 640107054510, 640107054610, 640107054703, 640107054809, 640107055203, 640107056603, 640107057103, 640107058108, 640107058511, 640107059811, 640107060203, 640107060620, 640107062003, 640107063020, 640107063408, 640107064108, 640107079007, 640107083104, 640107088406, 640107090004, 640107090304, 640107091904, 640107092006, 640107092605, 640107096206, 640107097404, 640107099505, 640107102706, 640107107206, 640107109405, 641805000172, 641805000252, 641805000455, 641805000555, 641805000564, 641805000568, 641805000660, 641805000765, 641805000856, 641805000862, 641805000956, 641805000957, 641805001157, 641805001258, 641807002969, 641807005165, 641807005465, 641807005859, 641807006053, 641807006068, 641807006763, 641807006866, 641807006955, 641807007664, 641807007766, 641807007861, 641807007866, 641807007964, 641807008052, 641807009162, 641807009660, 641807009962, 641807010758, 641807011158.
  • Product Classification
    Ophthalmic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution--USA (nationwide) including Puerto Rico.
  • Product Description
    AVAIRA AQUAFORM Comfort Science enfilcon A Daily Wear SPHERE Soft Contact Lenses (disposable), Rx only, STERILE --- CooperVision: Hamble, SO31 4RF, UK -- Scottsville, NY 14546 USA -- Juana Diaz, PR 00795 USA --- Device Listing # D033736. Packaged: 6 Soft Contact Lenses per unit carton or trial product 3 pack. || AVAIRA (enfilcon A) SPHERE soft contact lenses are indicated for the correction of ametropia (myopia or hyperopia) in aphakic and non-aphakic persons with non-diseased eyes. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.
  • Manufacturer
    Coopervision Inc.
Device Recall AVAIRA Soft Contact Lenses
  • Model / Serial
    10447500016006, 10519550007006, 10537500016014
  • Product Classification
    Ophthalmic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide, including Puerto Rico, and Canada.
  • Product Description
    AVAIRA (enfilcon A) Soft (Hydrophilic) Daily Wear Toric Contact Lenses
  • Manufacturer
    Cooper Vision Caribbean Corp.