Class 2 Device Recall Johnson and Johnson Vision Care 1 Day ACUVUE MOIST

• Date Initiated by Firm: July 23, 2018
• Create Date: August 23, 2018
• Recall Status: Terminated on December 06, 2021
• Recall Number: Z-2916-2018
• Recall Event ID: 80654
• 510(K)Number: K062614
• Product Classification: Lenses, soft contact, daily wear - Product Code LPL
• Product: 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.
• Code Information: 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.
• Recalling Firm/ Manufacturer: Johnson & Johnson Vision Care, Inc.; 7500 Centurion Pkwy; Jacksonville FL 32256-0517
• For Additional Information Contact: 904-443-1000
• Manufacturer 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.
• FDA Determined Cause: Equipment maintenance
• Action: 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.
• Quantity in Commerce: 195,660 Total; 89,640 US & Puerto Rico, 106,020 OUS
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = LPL and Original Applicant = JOHNSON & JOHNSON VISION CARE, INC.