Class 2 Device Recall ACUVUE VITA

• Date Initiated by Firm: May 06, 2021
• Create Date: June 16, 2021
• Recall Status: Terminated on November 02, 2021
• Recall Number: Z-1865-2021
• Recall Event ID: 87947
• 510(K)Number: K160212
• Product Classification: Lenses, soft contact, daily wear - Product Code LPL
• Product: ACUVUE VITA soft (hydrophilic) contact lens (spherical) for daily wear. Base Curve 8.8, Refractive Power -1.50
• Code Information: UPC 733905989612 LOT # BOOWWWL
• Recalling Firm/ Manufacturer: Johnson & Johnson Vision Care, Inc.; 7500 Centurion Pkwy; Jacksonville FL 32256-0517
• For Additional Information Contact: Customer Relations; 904-443-1000
• Manufacturer Reason for Recall: Potential that a limited number of individual contact lens packages have an incomplete packaging seal.
• FDA Determined Cause: Process control
• Action: On May 4th the firm sent a letter to its consignees with the following instructions: Since you have received potentially affected product, please immediately take the following actions: 1. Review your inventory and determine if you have ACUVUE Vita Brand Diagnostic lenses from the impacted lot: B00WWWL 2. STOP using and remove from your inventory all affected product. Note: You can continue to use all other lots not affected by this voluntary recall. 3. Please pass this notice on to anyone in your organization who needs to be aware of the issue and ensure that they maintain awareness as necessary. 4. Please contact your patients that may have received any of the affected product and ask them to discontinue use and return to you for replacement. 5. Customer Service, at 1-800-843-2020, will arrange for you the return and replacement of any affected product. 6. Complete the enclosed Customer Reply Form and return via fax to 904-443-3442 or via email to vpiweb@visus.jnj.com, EVEN IF YOU HAVE NO INVENTORY REMAINING affected by this recall. JJVC requires this information for reconciliation purposes with regulatory agencies. The completed Customer Reply Form should be faxed or emailed within 3 business days of receipt of this letter.
• Quantity in Commerce: 6,780 lenses
• Distribution: Worldwide Distribution. US nationwide, Canada, Germany, Austria, Belgium, France, Luxemburg, Netherland, Portugal, Spain, Sweden, Switzerland, and Trinidad and Tobago.
• 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