DAILIES TOTAL1, DAILIES TOTAL1 for Astigmatism, DAILIES TOTAL1 Multifocal, TOTAL30 Sphere,
FDA Device Recall #Z-3313-2024 - Class II, August 8, 2024
Recall Summary
| Recall Number | Z-3313-2024 |
| Classification | Class II - Moderate risk |
| Date Initiated | August 8, 2024 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Alcon Research LLC |
| Location | Fort Worth, TX |
| Product Type | Devices |
| Quantity | 92,835 Packs |
Product Description
DAILIES TOTAL1, DAILIES TOTAL1 for Astigmatism, DAILIES TOTAL1 Multifocal, TOTAL30 Sphere,
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 Pattern
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 Information
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
Other Recalls from Alcon Research LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0939-2026 | Class I | Brand Name: Alcon Laboratories, Inc. Product N... | Nov 24, 2025 |
| Z-0326-2026 | Class II | Alcon PRECISION1 One-Day Contact Lenses, -2.25D. | Sep 30, 2025 |
| Z-0581-2026 | Class II | CONSTELLATION ULTRAVIT 10K and CONSTELLATION HY... | Sep 15, 2025 |
| Z-0305-2026 | Class II | Brand Name: Alcon Laboratories, Inc. Product N... | Aug 5, 2025 |
| Z-0307-2026 | Class II | Brand Name: Alcon Laboratories, Inc. Product N... | Aug 5, 2025 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic, removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency, Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.