FDA Device recall Z-3313-2024
DAILIES TOTAL1, DAILIES TOTAL1 for Astigmatism, DAILIES TOTAL1 Multifocal, TOTAL30 Sphere
- FDA Device
- Class II
- ongoing
- Published 2024-10-09
On 2024-10-09 the FDA classified a Class II recall of DAILIES TOTAL1, DAILIES TOTAL1 for Astigmatism, DAILIES TOTAL1 Multifocal, TOTAL30 Sphere by Alcon Research, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3313-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-08-08 |
| Published | 2024-10-09 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Alcon Research |
| Distribution | AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY |
Product
DAILIES TOTAL1, DAILIES TOTAL1 for Astigmatism, DAILIES TOTAL1 Multifocal, TOTAL30 Sphere,
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.
Identifiers
| code_info | Product/UDI-DI(GTIN)/Expiration: Lots: DAILIES TOTAL1/00630175507808, 00630175507754, 00630175507181, 00630175507662, 0…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, 0084656689 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3313-2024%22
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