Recall Z-1515-2018
CooperVision Inc. · initiated February 21, 2018
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
Product
clariti 1 day/Fresh Day 90 pack (-1.00), UV Blocking, 90 silicon 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.
Codes / lots: Lot 14376100252004, Exp. Date 7/31/2020 (foil); 7/20/2031 (carton)
Reason for recall
The secondary packaging is labeled with an incorrect expiration date.
FDA-determined cause: Incorrect or no expiration date
Action taken
The firm, CooperVision, sent an "Firm Initiated Voluntary Removal - ACTION REQUIRED" letter to its customers on 2/21/18. The letter describes the product, problem and actions to be taken. The letters instructed customers to: Examine your inventory for any affected lot numbers; Stop any further distribution of the specified lot(s) of clariti 1 day and Fresh Day contact lenses; discard product and contact CooperVision, Inc. Customer Service department at 1-800-341-2020 to receive credit and/or complimentary replacement product. The removal only affects clariti 1 day lenses with the lot numbers specified on the enclosed letter. No other clariti 1 day and Fresh Day products or any other CooperVision products are affected. If you have any further questions, please feel free to contact your Account Representative or Customer Service at 1-800-341-2020, 9:00 AM 7:00 PM ET, Monday - Friday.
Details
- Recall number
- Z-1515-2018
- Initiated
- February 21, 2018
- Terminated
- October 2, 2019
- Product code
- MVN – Lens, Contact, (Disposable)
- Quantity
- 22 packs/1980 lenses
- 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.
- Recalling firm
- CooperVision Inc., W Henrietta, NY
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1516-2018 Class III | clariti 1 day (-1.25) 90 pack, UV Blocking, 90 silicone hydrogel, daily disposable…The secondary packaging is labeled with an incorrect expiration date. | 02/21/2018Terminated |
| Z-1517-2018 Class III | 56% 1 Day Silicone Hydrogel (-4.50), 10 pack, UV Blocking, daily disposable contact…The secondary packaging is labeled with an incorrect expiration date. | 02/21/2018Terminated |
| Z-1518-2018 Class III | 56% 1 Day Silicone Hydrogel (-2.50), 10 pack, UV Blocking, daily disposable contact…The secondary packaging is labeled with an incorrect expiration date. | 02/21/2018Terminated |