Class 2 Device Recall ACUVU E OASYS

• Date Initiated by Firm: December 18, 2017
• Create Date: April 17, 2020
• Recall Status: Terminated on June 10, 2020
• Recall Number: Z-1744-2020
• Recall Event ID: 85261
• 510(K)Number: K042275
• Product Classification: Lens, contact, (disposable) - Product Code MVN
• Product: ACUVUE OASYS for ASTIGMATISM Brand Contact Lenses. Lot no. B00NKM0G. Base Curve 8.6, Refractive Power -3.00D-1.25/90.
• Code Information: Lot no. B00NKM0G. Base Curve 8.6, Refractive Power -3.00D-1.25/90.
• FEI Number: 1000222023
• Recalling Firm/ Manufacturer: Johnson & Johnson Vision Care, Inc.; 7500 Centurion Pkwy; Jacksonville FL 32256-0517
• For Additional Information Contact: Abdiel Alvarez; 904-443-3794
• Manufacturer Reason for Recall: Package integrity failure observed during routine shift package integrity testing at an external re-packager.
• FDA Determined Cause: Packaging
• Action: Johnson & Johnson Vision Care Inc., notified customers on 12/18/2017 via Recall Notification letter. Included with the Recall Notification Letter was a Customer Reply Form which the customer is instructed to fax back to the firm.
• Quantity in Commerce: 150 lenses.
• Distribution: Nationwide US.
• 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 = MVN