Device product
56% 1 Day Silicone Hydrogel (-2.50), 10 pack, UV Blocking, daily disposable contact lenses The Clariti 1 Day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV blocker is indicated for daily wear single use only for the correction of refractiveametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.00 Dopters that does not interfere with visualacuity. Clariti 1 Day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UVblocker help protect against transmission of harmful UV radiation to the cornea andinto the eye.
Z-1518-2018
Product summary
- Event
- Event 79755
- Status
- Terminated
- Classification
- Class III
- Quantity
- 105 packs/1050 lenses
- Official record key
device-enforcement:Z-1518-2018
Official wording
Reason: The secondary packaging is labeled with an incorrect expiration date.
Code information: Lot 14364100370010, Exp. Date 3/31/2020 (foil); 5/31/2020 (carton)
Distribution pattern: US Nationwide Distribution to states of: AL, AR, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WY.
Derived failure modes
-
Unknown
The secondary packaging is labeled with an incorrect expiration date.