FDA recall Z-1518-2018

CooperVision Inc. · Class III · 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.

Reason for recall

The secondary packaging is labeled with an incorrect expiration date.

Distribution

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.

Key facts

Status
Terminated
Initiation date
2018-02-21
Report date
2018-05-02
Termination date
2019-10-02
Voluntary/Mandated
Voluntary: Firm initiated
Location
W Henrietta, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1518-2018