Z-3313-2024Class II

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

Name: Z-3313-2024 DAILIES TOTAL1, DAILIES TOTAL1 for Astigmatism, DAILIES TOTAL1 Multifocal, TOTAL30 Sphere
Creator: Alcon Research LLC
Published: 2024-08-08
License: https://open.fda.gov/license/

Alcon Laboratories / initiated 2024-08-08 / Open, Classified / root cause: labeling and UDI

FDA source

Alcon Research LLC began a recall of DAILIES TOTAL1, DAILIES TOTAL1 for Astigmatism, DAILIES TOTAL1 Multifocal, TOTAL30 Sphere on 2024-08-08. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-3313-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-08-08
Posted: 2024-09-30
Recalling firm: Alcon Laboratories
Product: DAILIES TOTAL1, DAILIES TOTAL1 for Astigmatism, DAILIES TOTAL1 Multifocal, TOTAL30 Sphere,
Product code: LPL Lenses, Soft Contact, Daily Wear
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.
Root cause tag: labeling and UDI
FDA 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 [email protected] 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 in commerce: 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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3313-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3313-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-10-09	2024-09-30

Product code LPL

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)