FDA-Device2024-10-09Class II

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

Alcon Research LLC
Hazard

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.

Sold states
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
Affected count
92,835 Packs
Manufactured in
6201 South Fwy, Aspex Facility, Fort Worth, TX, United States
Products
DAILIES TOTAL1, DAILIES TOTAL1 for Astigmatism, DAILIES TOTAL1 Multifocal, TOTAL30 Sphere,

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3313-2024

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