Alcon Research LLC: DAILIES TOTAL1, DAILIES TOTAL1 for Astigmatism, DAILIES TOTAL1 Multifocal, TOTAL30 Sphere

Recall number

Z-3313-2024

Recalling firm

Alcon Research LLC

Product

DAILIES TOTAL1, DAILIES TOTAL1 for Astigmatism, DAILIES TOTAL1 Multifocal, TOTAL30 Sphere,

Status

Open, Classified

Initiated

2024-08-08

Posted

2024-09-30

Terminated

not on file

Reason

Material with a quality issue was used in contact lens production, so contact lenses may not meet quality and/or performance standards for the entirety of their labeled shelf life, and wearing these lenses may lead to temporary issues such as irritation, redness, or blurred vision.

Root cause

Process change control

Action

On 8/8/24, recall notices were sent to customers who were asked to do the following: 1) Discontinue any further distribution of affected product. 2) Dispose of all affected product. If immediate destruction is not feasible, ensure the identified lots are segregated from unaffected products. 3) Forward this notification to departments within your organization who may be in possession of the affected product. 4) Contact other organizations, eye care providers and/or individuals to whom you have transferred or distributed the identified lots, and patients, and inform them of this Voluntary Medical Device Recall, and request they dispose of contact lenses from the identified lots. For your convenience, a notification template is enclosed for communicating this issue to your customers/patients. 3) Complete and return the response form via email to market.actions@alcon.com Alternately, respond via QR code: myalcon.com/notification-response-form If you have questions about the notice, or replacement process, or need electronic copies of the notification letter, call 1-888-266-7974

Quantity

92,835 Packs

Distribution

US: UT, TX, NC, MT, AL, WA, MS, PA, LA, MI, GA, FL, KY, OH, AZ, IL, CA, NJ, TN, NY, AR, MN, WI, MD, OK, SC, OR, MA, CO, VA, CT, IA, DE, WV, MO, ID, SD, NE, NV, IN, ME, VT, NM, NH, AK, HI, KS, RI, WY, PR, DC. OUS: GB, NL, HK, ES, PL, IT, FR, CA, CH, PT, AT, DE, NO, GG, LU, CZ, SK, DK, FI, SE, IN, OM, BE, QA, KW, SA, AE, LB, BH, HU, MY, IE, SG, IS, XI, MK, GI, MT, KR, SI, NZ, GR, GF, GP, MQ, TW, EE, GL, GE, IL, UA, FO, LV, AD, RS, LT, RO, SM, AZ, AU, JE, HR, AX, LI, CY, BG

Lot, serial or model codes

Product/UDI-DI(GTIN)/Expiration: Lots: DAILIES TOTAL1/00630175507808, 00630175507754, 00630175507181, 00630175507662, 00630175508423, 00630175507679, 00630175507778, 00630175507075, 00630175507730, 00630175507839, 00630175508362, 00630175508348, 00630175508393, 00630175508263, 00630175508324, 00630175507242, 00630175508256, 00630175507815, 00630175507266, 00630175508287, 00630175507846/ 3/31/2028: N1275784, N1275785, N1275787, N1275788, N1275790, N1275791, N1275792, N1275793, N1275794, N1275795, N1275796, N1275797, N1275798, N1275799, N1275800, N1275801, N1275802, N1275803, N1275804, N1276252, N1276256, N1276261, N1276262, N1276267, N1276268, N1276269, N1276270, N1276271, N1276272, N1276273, N1276766, N1276770, N1276771, N1276789, N1276790; 4/30/2028: N1277278, N1277291, N1277292, N1277293, N1277294, N1277319, N1277322, N1277795, N1277799, N1277805. DAILIES TOTAL1 for Astigmatism/00846566901746, 00846566874699, 00846566870714, 00846566903863, 00846566864935, 00846566861699, 00846566899418, 00846566866588, 00846566900930, 00846566868322, 00730822262408, 00846566906239, 00846566866069, 00846566865383, 00846566906222, 00846566865611, 00846566865369, 00846566862030, 00730822269025, 00846566901869, 00846566872954, 00846566901654, 00846566863358, 00730822266772, 00730822269476, 00846566900282, 00846566904297, 00730822262545, 00846566865314, 00846566879083, 00846566915132, 00730822264785, 00846566879212, 00730822264792, 00846566870240, 00846566875160, 00846566869428, 00846566874705, 00730822262095, 00846566878680, 00846566904068, 00846566906246, 00846566878314, 00730822264631, 00846566876952, 00846566868681, 00730822258272, 00846566878628, 00730822264990, 00846566869794, 00846566877812, 00846566867837, 00846566866434, 00846566879076, 00846566910779, 00846566879168, 00730822258241, 00846566898534, 00846566878307, 00846566868735, 00846566873876, 00846566879144, 00846566875115, 00846566877850, 00846566866038, 00730822260497, 00846566905799, 00846566862160, 00846566867530, 00730822266840, 00846566897698,00846566901715, 00846566902064, 00846566869770, 00846566863860, 00846566903931, 00846566906741, 00846566867981, 00846566905775, 00846566901630, 00846566869282, 00730822264914, 00730822258265, 00846566866632, 00730822256018, 00846566871070, 00846566905782, 00846566866281, 00846566902071, 00846566900763, 00846566868384, 00846566866786, 00846566863693, 00846566869589, 00846566866007, 00846566869053, 00846566871834, 00846566873180, 00846566862344, 00846566870035, 00846566870974, 00846566897278, 00846566879052, 00846566872282, 00846566870486, 00846566865567, 00846566865130, 00846566865901, 00846566871872, 00846566873630, 00846566865116, 00846566862436, 00846566864560, 00846566874538, 00846566868582, 00846566864218, 00846566869602, 00846566868155, 00846566864119, 00846566874088, 00846566869954, 00846566878154, 00846566872732, 00846566870950, 00846566879038, 00846566878932, 00846566868605, 00846566870509, 00846566869503, 00846566861439, 00846566878130, 00846566861514, 00846566867257, 00846566871407, 00846566878581, 00846566864621, 00846566865291, 00846566910687, 00730822266604, 00846566901210, 00730822264358, 00846566910656, 00846566865185, 00846566906116, 00846566906314, 00846566901616, 00846566908387, 00846566875139, 00846566901784, 00846566901708, 00846566877836, 00846566910632, 00846566901661, 00846566906185, 00730822266734, 00846566864492, 00846566879359, 00846566902187, 00846566867288, 00846566906260, 00846566901241, 00846566871674, 00846566899838, 00730822264334, 00846566869718, 00846566865154, 00846566898954, 00846566906277, 00846566910663, 00846566867103, 00846566901845, 00846566901647, 00846566906338, 00846566878642, 00846566870929, 00846566870417, 00846566869947, 00846566879021, 00846566906284, 00846566874231, 00846566874255/ 3/31/2029: N1275904, N1275908, N1275909, N1275913, N1275914, N1275918, N1275919, N1275921, N1275928, N1275929, N1275932, N1275935, N1275942, N1275943, N1275946, N1275954, N1275955, N1275956, N1275958, N1275991.N1275992, N1275997, N1275999, N1276003, N1276004, N1276005, N1276009, N1276010, N1276013, N1276018, N1276019, N1276025, N1276028, N1276043, N1276047, N1276048, N1276050, N1276051, N1276055, N1276057, N1276068, N1276069, N1276071, N1276073, N1276074, N1276076, N1276078, N1276079, N1276082, N1276083, N1276084, N1276087, N1276088, N1276091, N1276093, N1276094, N1276096, N1276098, N1276104, N1276107, N1276116, N1276121, N1276122, N1276124, N1276126, N1276130, N1276135, N1276136, N1276142, N1276143, N1276146, N1276150, N1276153, N1276154, N1276156, N1276157, N1276160, N1276164, N1276166, N1276167, N1276331, N1276336, N1276339, N1276342, N1276343, N1276345, N1276347, N1276354, N1276357, N1276360, N1276362, N1276365, N1276367, N1276371, N1276372, N1276376, N1276377, N1276379, N1276381, N1276385, N1276390, N1276393, N1276394, N1276395, N1276397, N1276398, N1276399, N1276402, N1276404, N1276407, N1276409, N1276411, N1276413, N1276428, N1276429, N1276431, N1276432, N1276435, N1276440, N1276441, N1276443, N1276445, N1276446, N1276449, N1276450, N1276451, N1276453, N1276454, N1276455, N1276458, N1276461, N1276463, N1276464, N1276468, N1276469, N1276472, N1276473, N1276475, N1276480, N1276482, N1276483, N1276484, N1276486, N1276488, N1276491, N1276494, N1276496, N1276505, N1276508, N1276509, N1276510, N1276511, N1276516, N1276523, N1276526, N1276537, N1276547, N1276551, N1276572, N1276575, N1276578, N1276579, N1276582, N1276589, N1276612, N1276617, N1276621, N1276628, N1276649, N1276653, N1276863, N1276866, N1276876, N1276878, N1276890, N1276891, N1276897, N1276932, N1276942, N1276944, N1276950, N1277084, N1277123, N1277132, N1277136, N1277137, N1277150, N1277160, N1277164, N1277367; 4/30/2029: N1277411, N1277427, N1277443, N1277449, N1277518, N1277564, N1277598, N1277611, N1277624, N1277625, N1277654, N1277897, N1277911, N1278101, N1278309, N1278317, N1278371, N1278378, N1278621, N1278644, N1278649, N1278658, N1278728, N1278729, N1278742, N1278750, N1278751, N1278763, N1278764, N1278765, N1278770, N1278783, N1278795, N1278814, N1278828, N1278850, N1278986, N1279005, N1279021, N1279094, N1279142, N1279156, N1279346, N1279370, N1279437, N1279441, N1279446, N1279455, N1279465. DAILIES TOTAL1 Multifocal/00846566847112, 00846566850341, 00846566850235, 00846566850273, 00846566850259, 00846566850280, 00846566849581, 00846566851355, 00846566849383, 00846566845668, 00846566847983, 00846566849932, 00846566850686, 00846566850570, 00846566851386, 00846566851331, 00846566848881, 00846566848324, 00846566848386, 00846566848898, 00846566848348, 00846566847587, 00846566850839, 00846566850846, 00846566850297, 00846566850266, 00846566847488, 00846566847280, 00846566850563, 00846566850372, 00846566849789, 00846566850426, 00846566849888, 00846566851058, 00846566851188, 00846566849048, 00846566850921, 00846566850242, 00846566849598, 00846566845729, 00846566848676, 00846566848591, 00846566846382, 00846566850518, 00846566850440, 00846566850662, 00846566850624, 00846566849178, 00846566847846, 00846566848652, 00846566851096, 00846566849208, 00846566845927, 00846566849956, 00846566851126, 00846566846375, 00846566850600, 00846566846214, 00846566850891, 00846566847228, 00846566850853, 00846566850198, 00846566850310, 00846566850204, 00846566848485, 00846566846528, 00846566849901, 00846566849093, 00846566848607, 00846566849741, 00846566851041, 00846566851089, 00846566851201, 00846566850433, 00846566850938, 00846566850914, 00846566846320, 00846566850464, 00846566847051, 00846566849895, 00846566846436,00846566846153, 00846566846146, 00846566849734, 00846566850549, 00846566850389, 00846566848263, 00846566850228, 00846566850907, 00846566850860, 00846566850211, 00846566850457, 00846566848447, 00846566850396, 00846566851195, 00846566849222, 00846566848416, 00846566851171, 00846566849871, 00846566849109, 00846566850495, 00846566847860, 00846566851140, 00846566850884, 00846566847730, 00846566848393, 00846566849123, 00846566848492, 00846566850501, 00846566851102, 00846566851317/ 3/31/2029: N1275728, N1275730, N1275731, N1275732, N1275733, N1275736, N1275739, N1275740, N1275741, N1275744, N1275751, N1275752, N1275753, N1275754, N1275761, N1275767, N1275769, N1275770, N1275773, N1275805, N1275806, N1275807, N1275808, N1275809, N1275811, N1275812, N1275813, N1275814, N1275815, N1275816, N1275817, N1275818, N1275819, N1275820, N1275821, N1275822, N1275823, N1275824, N1275827, N1275829, N1275830, N1275831, N1275847, N1275849, N1275852, N1275855, N1275857, N1275858, N1275860, N1276178, N1276180, N1276181, N1276183, N1276189, N1276198, N1276199, N1276201, N1276203, N1276209, N1276210, N1276212, N1276213, N1276216, N1276219, N1276220, N1276221, N1276222, N1276223, N1276224, N1276232, N1276233, N1276234, N1276235, N1276237, N1276239, N1276242, N1276243, N1276275, N1276276, N1276281, N1276286, N1276288, N1276291, N1276292, N1276293, N1276294, N1276303, N1276304, N1276305, N1276306, N1276308, N1276311, N1276313, N1276314, N1276316, N1276317, N1276320, N1276321, N1276323, N1276325, N1276327, N1276689, N1276695, N1276703, N1276714, N1276728, N1276793, N1276848, N1277330, N1277331, N3500526, N3500528, N3500530, N3500531, N3500532, N3500534, N3500536; 4/30/2029: N1277754, N1278436, N1278440, N1278444, N1278446, N1278448, N1278454, N1278455, N1278457, N1278460, N1278461, N1278464, N1278472, N1278475, N1278476, N1278478, N1278482, N1278485, N1278489, N1278506, N1278507, N1278508, N1278586, N1278587, N1278588, N1278597, N1278598, N1278600, N1278606, N1279162, N1279163, N1279165, N1279166, N1279190, N1279193, N1279194, N1279217, N1279221, N1279223, N1279311, N1279314, N1279319. TOTAL30 Sphere/00730822287708, 00730822287739, 00730822287654, 00730822287616, 00730822287630, 00730822287746, 00730822287791, 00730822287685, 00730822287593, 00730822287692, 00730822287678, 00730822287647, 00730822287760, 00730822287906, 00730822288477, 00730822287753, 00730822287487, 00730822287449, 00730822287401, 00730822287807, 00730822287333, 00730822287395, 00730822287777, 00730822287463, 00730822287784, 00730822287562, 00730822287623, 00730822288385, 00730822287722, 00730822287609, 00730822287715, 00730822287814, 00730822287661, 00730822288415, 00730822288293, 00730822288309, 00730822288361, 00730822288323/ 3/31/2031: N4159824, N4159826, N4159828, N4159830, N4159832, N4159834, N4159838, N4159840, N4159842, N4159844, N4159846, N4159848, N4159854, N4159856, N4159858, N4159860, N4159866, N4159870, N4159872, N4160926, N4160927, N4160928, N4160929, N4160930, N4160930, N4160931, N4160931, N4160932, N4160933, N4160934, N4160934, N4160936, N4160938, N4160939, N4160941, N4160942, N4160943, N4160944, N4160945, N4160946, N4160947, N4160948, N4160952, N4160953, N4160954, N4160955, N4160957, N4162814, N4162815, N4162817, N4162818, N4162819, N4162820, N4162821, N4162822, N4162823, N4162825, N4162826, N4162827, N4162828, N4162829, N4162830, N4162831, N4162832, N4162833, N4162834, N4162835, N4162836, N4162837, N4162838, N4162839, N4162840, N4162841, N4162842, N4162843, N4162844, N4162845, N4162846, N4162847, N4162848, N4162849, N4162850, N4162852, N4162853, N4162854, N4162855, N4162857, N4162858, N4162859, N4162860, N4162861, N4162862, N4162863, N4162864, N4162865, N4162866, N4162867, N4162868, N4162869, N4162870, N4162873, N4162874, N4162876, N4162877

510(k) numbers

["K232921","K233856"]

PMA numbers

not on file

Product code

LPL

Firm FEI

1610287

Firm city

Fort Worth

Firm state

TX

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

Copy