Device Recall AVAIRA (enfilcon A) Daily Wear Sphere Contact Lens

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, 10433000010508, 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10435000017022, 10435000017028, 10435000018005, 10435000018017, 10435000018023, 10435000018024, 10435000019003, 10435000019009, 10435000019026, 10435000020003, 10435000020005, 10435000020006, 10435000020010, 10435000020019, 10435000020024, 10435000021004, 10435000021005, 10435000021009, 10435000021014, 10435000022005, 10435000023004, 10435000023005, 10435000023006, 10435000023007, 10435000023009, 10435000023015, 10435000023017, 10435000024004, 10435000024006, 10435000025006, 10435000025011, 10435000025013, 10435000026004, 10435000026005, 10435000026006, 10435000026007, 10435000026008, 10435000027006, 10435000027007, 10435000027011, 10435000028006, 10435000029006, 10435000029008, 10435000030008, 10435000031008, 10435050000028, 10435050001003, 10435050001026, 10435050001034, 10436000003040, 10436000004002, 10436000004004, 10436000004030, 10436000004516, 10436000005023, 10436000005026, 10436000005030, 10436000005518, 10436000006004, 10436000006017, 10436000006021, 10436000006024, 10436000006513, 10436000006514, 10436000007009, 10436000007012, 10436000007013, 10436000007016, 10436000007020, 10436000007024, 10436000007514, 10436000008005, 10436000008006, 10436000008012, 10436000008013, 10436000008014, 10436000009005, 10436000009007, 10436000009013, 10436000010005, 10436000010006, 10436000010007, 10436000010008, 10436000011005, 10436000011006, 10436000012006, 10436000012008, 10436050000026, 10436050001002, 10436050001510, 10613000003003, 10613000003010, 10613000004002, 10613000004016, 10613000004017, 10613000004514, 10613000005005, 10613000005007, 10613000005011, 10613000005036, 10613000005511, 10613000005515, 10613000006005, 10613000007017, 10613050000002, 10613050000005, 10613050000013, 10613050000019, 10613050000021, 10613050000022, 10613050000518, 10613050001003, 10613050001004, 10613050001005, 10613050001006, 10613050001007, 10613050001008, 10613050001009, 10613050001013, 10613050001014, 10613050001015, 10613050001018, 10613050001021, 10613050002004, 10613050002006, 10613050002020, 10613050003004, 10616000002042, 10616000004014, 10616000004036, 10616000004038, 10616000004517, 10616000004519, 10616000005009, 10616000005012, 10616000005018, 10616000005034, 10616000005514, 10616000005516, 10616000006008, 10616000006010, 10616000006013, 10616000006016, 10616000006017, 10616000006030, 10616000006510, 10616000006512, 10616000007003, 10616000007008, 10616000007009, 10616000007030, 10616000008003, 10616000008005, 10616000008010, 10616000008015, 10616000008020, 10616000008023, 10616000008024, 10616000008030, 10616000009005, 10616000009017, 10616000009024, 10616000009028, 10616000009030, 10616000010003, 10616000010005, 10616000010010, 10616000010021, 10616000010024, 10616000011003, 10616000011004, 10616000011007, 10616000011010, 10616000012002, 10616000012004, 10616000012005, 10616000012026, 10616000013004, 10616000013006, 10616000013026, 10616000014002, 10616050000008, 10616050000012, 10616050000013, 10616050000021, 10616050000032, 10616050000513, 10616050001004, 10616050001023, 10616050002004, 10616050002007, 10616050003005, 10796000003006, 10796000003024, 10796000003028, 10796000003030, 10796000004026, 10813000002003, 10813000002008, 10813000002010, 10813000002012, 10813000002014, 10813000002018, 10813000002022, 10813000002026, 10813000002030, 10813000002036, 10813000002040, 10813000003004, 10813050000006, 456405000016, 456405000035, 456405000060, 456405000214, 456405000313, 456405000328, 456405000403, 456405000504, 456405000510, 456405000520, 456405000607, 456405000620, 456405000708, 456405000709, 456405000717, 456405000805, 456405000808, 456405000809, 456405000905, 456405000906, 456405000909, 456405001005, 456405001006, 456405001106, 456407002233, 456407003169, 456407003551, 456407003835, 456407004434, 456407005165, 456407005934, 456407006255, 456407006736, 456407006759, 456407007032, 456407007132, 456407007459, 456407007464, 456407007664, 456407007752, 456407007757, 456407008066, 456407008154, 456407008661, 456407008862, 456407009662, 456407010858, 456407012830, 456407015130, 456407017028, 456407032626, 456407035002, 456407035026, 456407035223, 456407035523, 456407036702, 456407040418, 456407041322, 456407043413, 456407048014, 456407049713, 456407049824, 456407057910, 456407060103, 456407061510, 456407063915, 456407081207, 456407084904, 456407090505, 456407092206, 456407093304, 456407095305, 456407096506, 456407100004, 458505000028, 458505000062, 458507003835, 458507005368, 458507008057, 458507035523, 458507058711, 458507059811, 458507064215, 458605000226, 458605000410, 458605000419, 458605000510, 458605000610, 458605000613, 458605000615, 458605000712, 458605000713, 458605000809, 458605000813, 458605000814, 458605000815, 458605000816, 458605000908, 458605000911, 458605000914, 458605001004, 458605001108, 458605001116, 458605001204, 458605001205, 458605001206, 458605001207, 458605001304, 458605001305, 458605001306, 458605001406, 458605001506, 458605001606, 458605001607, 458605001706, 458605001707, 458605001806, 458605001807, 458605001906, 458607002651, 458607002933, 458607003232, 458607003335, 458607003732, 458607004865, 458607005268, 458607007257, 458607007861, 458607007866, 458607008064, 458607008154, 458607008432, 458607009262, 458607009501, 458607010730, 458607012458, 458607013130, 458607014030, 458607033726, 458607034902, 458607045121, 458607045221, 458607047424, 458607048814, 458607049014, 458607049824, 458607051816, 458607063515, 458607099805, 458607116806, 458705000051, 458705000161, 458705000163, 458705000226, 458705000259, 458705000352, 458705000366, 458705000460, 458705000466, 458705000532, 458705000628, 458705000632, 458705000728, 458705000730, 458705000732, 458705000807, 458705000813, 458705000828, 458705000913, 458705000914, 458705001009, 458705001108, 458705001118, 458705001210, 458705001402, 458705001411, 458705001502, 458705001823, 458705002221, 458705002903, 458705002906, 458705003005, 458705003006, 458705003105, 458705003106, 458705003205, 458705003206, 458707002233, 458707002633, 458707002651, 458707002751, 458707002969, 458707003335, 458707004234, 458707004534, 458707004865, 458707004867, 458707005265, 458707005672, 458707005959, 458707006232, 458707006253, 458707006255, 458707006457, 458707006557, 458707006632, 458707006736, 458707006755, 458707006852, 458707006866, 458707006932, 458707006952, 458707007063, 458707007257, 458707007459, 458707007664, 458707007861, 458707007866, 458707008066, 458707008154, 458707008560, 458707008661, 458707008760, 458707008862, 458707009262, 458707009360, 458707009662, 458707009930, 458707009962, 458707010360, 458707010630, 458707010656, 458707010858, 458707010956, 458707011756, 458707012030, 458707012256, 458707012258, 458707012430, 458707013928, 458707014030, 458707014628, 458707026126, 458707027026, 458707028226, 458707031302, 458707032302, 458707033102, 458707033926, 458707034423, 458707034623, 458707034626, 458707034902, 458707034923, 458707039118, 458707039218, 458707042917, 458707043413, 458707044517, 458707046921, 458707047221, 458707047224, 458707047319, 458707048014, 458707049924, 458707050013, 458707056112, 458707056409, 458707058010, 458707059811, 458707060008, 458707061510, 458707062820, 458707063008, 458707064915, 458707065215, 458707072307, 458707082904, 458707090304, 458707092904, 458707093106, 458707093804, 458707094005, 458707095704, 458707096005, 458707099005, 458707103306, 458707109006, 489405000057, 489405000130, 489405000217, 489405000218, 489405000230, 489405000260, 489405000263, 489405000302, 489405000328, 489405000362, 489405000416, 489405000418, 489405000426, 489405000428, 489405000516, 489405000521, 489405000522, 489405000528, 489405000622, 489405000724, 489405000803, 489405000809, 489405000812, 489405000907, 489405000910, 489405000913, 489405001010, 489405001107, 489405001109, 489405001110, 489405001113, 489405001204, 489405001207, 489405001304, 489405001305, 489405001307, 489405001407, 489405001505, 489405001605, 489405001606, 489405001705, 489405001706, 489405001806, 489405001906, 489405002006, 489407002969, 489407003169, 489407003232, 489407003335, 489407003551, 489407004067, 489407004167, 489407004534, 489407004632, 489407004734, 489407005265, 489407005665, 489407005672, 489407005832, 489407006053, 489407006557, 489407006653, 489407006755, 489407006866, 489407006932, 489407007464, 489407007657, 489407007664, 489407007752, 489407007964, 489407008057, 489407008066, 489407008154, 489407008561, 489407008862, 489407009162, 489407009360, 489407009930, 489407010101, 489407010362, 489407010430, 489407010656, 489407010858, 489407016828, 489407018428, 489407033326, 489407034223, 489407035002, 489407044417, 489407046819, 489407046924, 489407047114, 489407048814, 489407049924, 489407055509, 489407058911, 489407061510, 489407062808, 489407064208, 489407086504, 489407094405, 489407100306, 489407102304, 489407106706, 491305000059, 491305000066, 491305000133, 491305000156, 491305000254, 491305000262, 491305000432, 491305000460, 491305000464, 491305000528, 491305000530, 491305000628, 491305000630, 491305000728, 491305000730, 491305000828, 491305000830, 491305000928, 491305001023, 491305001026, 491305001104, 491305001122, 491305001126, 491305001204, 491305001217, 491305001222, 491305001223, 491305001226, 491305001304, 491305001310, 491305001317, 491305001324, 491305001326, 491305001404, 491305001408, 491305001410, 491305001418, 491305001424, 491305001426, 491305001505, 491305001510, 491305001518, 491305001519, 491305001526, 491305001605, 491305001607, 491305001608, 491305001609, 491305001610, 491305001611, 491305001613, 491305001626, 491305001705, 491305001707, 491305001712, 491305001713, 491305001807, 491305001808, 491305001809, 491305001810, 491305001816, 491305001907, 491305001916, 491305001920, 491305002006, 491305002007, 491305002016, 491305002106, 491305002107, 491305002206, 491305002306, 491305002506, 491307001633, 491307002873, 491307002969, 491307003169, 491307003333, 491307003551, 491307003835, 491307004167, 491307004734, 491307004865, 491307005368, 491307005472, 491307006253, 491307006457, 491307006536, 491307006755, 491307006759, 491307006866, 491307007032, 491307007063, 491307007332, 491307007752, 491307007866, 491307008064, 491307008154, 491307008157, 491307008560, 491307008561, 491307008661, 491307008962, 491307010101, 491307010162, 491307010362, 491307010858, 491307012458, 491307012556, 491307018728, 491307019628, 491307033602, 491307046713, 491307046924, 491307048216, 491307057711, 491307058609, 491307059909, 491307063408, 491307063520, 491307078007, 491307093106, 508205000533, 508205000633, 508205000634, 508205000637, 508205000732, 508205000733, 508205000734, 508205000736, 508205000832, 508205000835, 508205000932, 508205001032, 508205001101, 508205001132, 508205001228, 508205001230, 508205001328, 508205001330, 508205001428, 508205001430, 508205001502, 508205001528, 508205001530, 508205001602, 508205001603, 508205001626, 508205001628, 508205001630, 508205001702, 508205001726, 508205001728, 508205001730, 508205001802, 508205001828, 508205001830, 508205001902, 508205001903, 508205001926, 508205001928, 508205002002, 508205002003, 508205002026, 508205002102, 508205002103, 508205002126, 508205002203, 508205002226, 508205002303, 508205002326, 508205002403, 508205002423, 508205002426, 508205002503, 508205002523, 508205002526, 508205002603, 508205002621, 508205002626, 508205002721, 508205002723, 508205002724, 508205002726, 508205002823, 508205002826, 508205002921, 508205002926, 508205003019, 508205003020, 508205003021, 508205003022, 508205003023, 508205003024, 508205003026, 508205003120, 508205003122, 508205003224, 508205003320, 508205003322, 508205003324, 508205003418, 508205003420, 508205003424, 508205003518, 508205003519, 508205003524, 508205003618, 508205003620, 508205003718, 508205003719, 508205003724, 508205003819, 508205003820, 508205003918, 508205003924, 508205004314, 508205004317, 508205004414, 508205004417, 508205004514, 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508205006506, 508205006508, 508205006509, 508205006513, 508205006604, 508205006605, 508205006606, 508205006608, 508205006609, 508205006704, 508205006706, 508205006709, 508205006713, 508205006715, 508205006804, 508205006805, 508205006806, 508205006904, 508205006905, 508205006906, 508205006909, 508205007005, 508205007006, 508205007105, 508205007106, 508205007108, 508205007109, 508205007205, 508205007206, 508205007305, 508205007306, 508205007309, 508205007405, 508205007406, 508205007408, 508205007410, 508205007506, 508205007509, 508205007510, 508205007606, 508205007607, 508205007706, 508205007710, 508205007806, 508205007810, 508205007906, 508205007910, 508205008006, 508205008010, 508205008106, 508205008206, 508205008210, 508205008306, 508205008406, 508205008407, 508205008506, 508205008507, 508205008606, 508205008607, 508205008707, 508205008807, 508205008907, 508205009007, 508205009107, 508205009207, 508205009307, 508205009407, 508205009507, 508205009607, 508205009707,  508205009807, 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508405001302, 508405001309, 508405001313, 508405001326, 508405001403, 508405001410, 508405001416, 508405001503, 508405001506, 508405001509, 508405001517, 508405001520, 508405001606, 508405001609, 508405001616, 508405001617, 508405001624, 508405001706, 508405001707, 508405001711, 508405001722, 508405001806, 508405001807, 508405001904, 508405001906, 508405001907, 508405001912, 508405001915, 508405002004, 508405002005, 508405002006, 508405002007, 508405002012, 508405002015, 508405002104, 508405002105, 508405002106, 508405002107, 508405002108, 508405002112, 508405002204, 508405002205, 508405002206, 508405002207, 508405002208, 508405002305, 508405002306, 508405002405, 508407000833, 508407003232, 508407003482, 508407003551, 508407003833, 508407003934, 508407004067, 508407004734, 508407005170, 508407005265, 508407005332, 508407005572, 508407005768, 508407006053, 508407006334, 508407008254, 508407009360, 508407009960, 508407010101, 508407012156, 508407012258, 508407012430, 508407012458, 508407039822, 508407045121, 508407049824, 508407055203, 508407058709, 508407058711, 508407065215, 508407094705, 639505000072, 639505000168, 639505000268, 639505000308, 639505000506, 639505000507, 639505000606, 639505000705, 639505000713, 639507002133, 639507004534, 639507007032, 639507007866, 639507007961, 639507009930, 639507010230, 639507012628, 639507017028, 639507026626, 639507035523, 639507037202, 639507039222, 639507047124, 639507051116, 639507056212, 639507060203, 639507060720, 639605000020, 639607003335, 639607004534, 639607007332, 639607010101, 639607017128, 639607062003, 639607063808, 639607087207, 639607091204, 639607091605, 639607093805, 639607101206, 639705000022, 639705000030, 639705000065, 639705000102, 639705000124, 639705000132, 639705000163, 639705000306, 639705000314, 639705000316, 639705000326, 639705000405, 639705000408, 639705000411, 639705000426, 639705000506, 639705000604, 639705000804, 639707000833, 639707002133, 639707004534, 639707004865, 639707005170, 639707005265, 639707005665, 639707006036, 639707006159, 639707006255, 639707006457, 639707006755, 639707006932, 639707006952, 639707007066, 639707007257, 639707007861, 639707008057, 639707008064, 639707008066, 639707008460,  639707008962, 639707009501, 639707009930, 639707010162, 639707010230, 639707010360, 639707010362, 639707010730, 639707010858, 639707012256, 639707012258, 639707012628, 639707012830, 639707014030, 639707014128, 639707014728, 639707017728, 639707033026, 639707033102, 639707033602, 639707033802, 639707033926, 639707034923, 639707035523, 639707037526, 639707038518, 639707040722, 639707041517, 639707042417, 639707044013, 639707044417, 639707046714, 639707046813, 639707046821, 639707048019, 639707048614, 639707049824, 639707054312, 639707054703, 639707056603, 639707057103, 639707059010, 639707059803, 639707060503, 639707060620, 639707063008, 639707064215, 639707067207, 639707068107, 639707069307, 639707071907, 639707073107, 639707084404, 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.

Ophthalmic Devices

2

No

Worldwide Distribution--USA (nationwide) including Puerto Rico.

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.