Johnson and Johnson Vision Care 1-Day ACUVUE MOIST Daily Wear, 8.5 Base Curve, -3.25 Power. Master Lot, containing 12 split lots, repackaged in 30 and 90-packs . Intended for daily disposable wear for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who may have 1.00D or less of astigmatism.
This recall has been terminated (originally issued July 23, 2018).
- Recall Initiated
- July 23, 2018
- Terminated
- December 6, 2021
- Recall Number
- Z-2916-2018
- Quantity
- 195,660 Total; 89,640 US & Puerto Rico, 106,020 OUS
- Firm Location
- Jacksonville, FL
- Official Source
- View on FDA website ↗
Reason for Recall
Johnson and Johnson Vision Care received a number of reports of a partially formed contact lens, which appears to the customer or consumer as visibly smaller in diameter, thicker/stiffer to the touch and more darkly tinted blue than the normal contact lens.
Distribution
Worldwide distribution: US (Nationwide) distribution to CA, CT, FL, GA, IA, IL, MA, MD, ME, MO, NC, NE, NH, NJ, NY, OH, PA, TN, TX, UT, and VA, Puerto Rico; and countries of: Canada, Barbados, Japan, and Korea.
Lot / Code Info
Master Lot Number 516191. 90 Pack Lot Number (US, PR, Canada, Barbados) 5165915104 which contains 30 pack lot numbers: 5165910104, 5165910105, 5165910106, 5165910107, 5165910108, 5165910109. 90 Pack Lot Number (Japan) 5165915110 which contains 30 pack lot numbers: 5165910110, 5165910111, 5165910112. 90 Pack Lot Number (Korea and Japan) 5165915101 which contains 30 pack lot numbers: 5165910101, 5165910102, 5165910103. Unique Device Identifier (UDI): 733905577215, 733905615078, and 733905888472.
Root Cause
Equipment maintenance
Action Taken
On July 23, 2018, the Johnson & Johnson notified customers of the recall via an "URGENT FIELD SAFETY NOTICE" letter date July 23, 2018. The letter to US and international customers included the following instructions: review inventory and determine if any affected product is on hand, cease using any affected product, provide the recall notification to anyone within the organization who needs to be aware of the recall, return any affected product and arrange for replacement product, and complete and return the enclosed Customer Reply Form. The distributor notification included a copy of the appropriate recall notification depending on the country they are located in as well as the following instructions: to cease distribution of any affected inventory, remove from inventory any affected product, distribute the included RECALL NOTIFICATION to all customers where product was further distributed, ensure customers understand the importance of completing and returning the Customer Reply Form, arrange for the return of any affected product on hand. If you have any questions, contact Sr. Director, Worldwide Quality Systems Strategy at 904-443-3794 or aalvar56@its.jnj.com. Also contact Project Manager, Escalation & Field Actions, phone 904-443-3516, email amyers@its.jnj.com.