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U.S. Department of Health and Human Services

Class 2 Device Recall ACUVUE OASYS for ASTIGMATISM

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  Class 2 Device Recall ACUVUE OASYS for ASTIGMATISM see related information
Date Initiated by Firm March 11, 2019
Date Posted April 11, 2019
Recall Status1 Terminated 3 on December 06, 2021
Recall Number Z-1131-2019
Recall Event ID 82402
510(K)Number K042275  
Product Classification Lenses, soft contact, daily wear - Product Code LPL
Product ACUVUE OASYS for ASTIGMATISM brand contact lenses, Base Curve 8.6 Refractive Power -1.00D, -1.25D x 100, 6 pack.
Code Information Lot Number on box and individual contact lens package: B00RWF0. UPC: 733905669460
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
One lot of ACUVUE OASYS¿ for ASTIGMATISM Brand Contact lenses has the potential for a limited number of individual contact lens packages to have an incomplete packaging seal.
FDA Determined
Cause 2
Equipment maintenance
Action Johnson & Johnson Vision Care, Inc. notified the single distributor on about 03/11/2019 via "URGENT ACTION: VOLUNTARY and LIMITED MEDICAL DEVICE RECALL" letter. The letter instructed the consignee to review their inventory to determine if any affected contact lenses are on hand, stop using all affected lenses, provide the recall notification to anyone within the organization that should be aware of the issue, and notify any customers may have received any affected product and request they discontinue use and return any on hand. They advised the consignee to contact Customer Service at 1-800-843-2020 to arrange for the return and replacement of affected lenses, and they were requested to complete and return the Customer Reply Form.
Quantity in Commerce 300 lenses
Distribution Distributed to California.
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 = VISTAKON
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