DAILIES TOTAL1, DAILIES TOTAL1 for Astigmatism, DAILIES TOTAL1 Multifocal, TOTAL30 Sphere,
- Company
- Alcon Research Llc
- Recall Initiated
- August 8, 2024
- Posted
- September 30, 2024
- Recall Number
- Z-3313-2024
- Quantity
- 92,835 Packs
- Firm Location
- Worth, TX
Reason for Recall
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.
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 / Code Info
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
Root Cause
Process change control
Action Taken
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