| Class 2 Device Recall 1DAY ACUVUE Moist for ASTIGMATISM Brand Contact Lenses | |
Date Initiated by Firm | October 19, 2017 |
Create Date | March 27, 2018 |
Recall Status1 |
Terminated 3 on June 12, 2020 |
Recall Number | Z-1211-2018 |
Recall Event ID |
79152 |
510(K)Number | K051900 |
Product Classification |
Lens, contact, (disposable) - Product Code MVN
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Product | 1-DAY ACUVUE Moist for ASTIGMATISM Brand Contact Lenses |
Code Information |
Lot B00LF41 Exp. 04/2021 Base Curve 8.5 Refractive Power -7.50D -1.25/180 Manufactured at J&J Vision Care Inc. Jacksonville, FL |
Recalling Firm/ Manufacturer |
Johnson & Johnson Vision Care, Inc. 7500 Centurion Pkwy Jacksonville FL 32256-0517
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For Additional Information Contact | 904-443-1000 |
Manufacturer Reason for Recall | Some contact lenses were associated with complaints of a foreign matter caught between the blister package and foil. |
FDA Determined Cause 2 | Packaging process control |
Action | On October 19, 2017, Johnson and Johnson sent letters to their customers stating the recall of ACUVUE and given the instructions to review their inventory, stop using the affected lots, use the enclosed label to return any affected products, contact customer service to arrange the return, even if they do not have any recall product inventory. A contact was provided to each individual letter. |
Quantity in Commerce | 56,070 |
Distribution | Worldwide distribution. US nationwide including Puerto Rico,
Korea, Czech Republic, China, Japan, Great Britain, Austria, Malaysia, Hong Kong, Russia, Taiwan, Singapore, India, and Brazil |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = MVN
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