Z-1516-2018 Class III Terminated
FDA device recall Z-1516-2018 was initiated by CooperVision Inc. on Feb 21, 2018 and is designated Class III. Reason for recall: The secondary packaging is labeled with an incorrect expiration date. The recall status is terminated (terminated Oct 2, 2019). Affected quantity: 32 packs/2880 lenses.
Recall Details
- Product Type
- Devices
- Report Date
- May 2, 2018
- Initiation Date
- Feb 21, 2018
- Termination Date
- Oct 2, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 32 packs/2880 lenses
Product Description
clariti 1 day (-1.25) 90 pack, UV Blocking, 90 silicone hydrogel, 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.
Reason for Recall
The secondary packaging is labeled with an incorrect expiration date.
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.
Code Information
Lot 14377101733005, Exp. Date 6/30/2020 (foil); 6/20/2030 (carton)
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1516-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026