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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 95249

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
August 08, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Alcon Research LLC

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Z-3313-2024
Recall number
Z-3313-2024
Initiated
August 08, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Alcon Research LLC
Quantity
92,835 Packs

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

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.

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

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