Recall Z-3313-2024 · LPL Lenses, Soft Contact, Daily Wear
Alcon Research LLC
DAILIES TOTAL1, DAILIES TOTAL1 for Astigmatism, DAILIES TOTAL1 Multifocal, TOTAL30 Sphere,
| Date | Sep 30, 2024 (initiated Aug 8, 2024) |
| Status | Open, Classified |
| 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. |
| 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 Medic |
| Quantity | 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 |
| FDA record | Open on fda.gov |