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U.S. Department of Health and Human Services

Class 2 Device Recall REFRESH CONTACTS Contact Lens Comfort Drops

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  Class 2 Device Recall REFRESH CONTACTS Contact Lens Comfort Drops see related information
Date Initiated by Firm December 29, 2020
Create Date February 03, 2021
Recall Status1 Terminated 3 on March 23, 2023
Recall Number Z-0948-2021
Recall Event ID 87058
510(K)Number K992028  
Product Classification Accessories, soft lens products - Product Code LPN
Product REFRESH CONTACTS¿ Contact Lens Comfort Drops 0.4 fl oz (12 mL) Sterile
Code Information Model Number: 91822US UDI Code: (01)00300231822120(17)230705(10)T0464A Lot Number: T0464A
Recalling Firm/
Manufacturer		 Allergan PLC
2525 Dupont Dr
Irvine CA 92612-1531
For Additional Information Contact Nicole Katz
862-261-7084
Manufacturer Reason
for Recall		 Missing Instruction For Use insert.
FDA Determined
Cause 2		 Employee error
Action On 12/29/2020, the firm sent an "URGENT DEVICE RECALL" to customers via overnight tracked mail informing them the affected lot is missing the instructions for use and safety information referenced on the carton. Customers are instructed to: 1. Quarantine the product that they have in their inventory 2. Carry out a physical count of the affected product and record the count on the enclosed Business Response Form (BRF). 3. Send the BRF to the Recalling Firm via email within five (5) business days of receipt. To ensure that the Recalling Firm is able to account for all recalled product, it is imperative that customers return the form. Return the BRF even if they have no recalled product to return. 4. Upon receipt of the BRF, the Recalling firm will issue a pre-paid return shipping label for return of the recalled product. 5. If customers have further distributed any of the affected product lot, the Recalling Firm is asking that customers notify these customers down to the Retail/Health Care Provider level. In the notification to their customers, they are asked to include the BRF, ACTIONS REQUIRED and CONTACT INFORMATION. 6. Do Not return any product lots that are not the subject of this recall. For questions contact or additional informaiton: Product Returns - Quality@allergan.com 862-261-7249 8am - 4:30pm EST Adverse Events - 800-678-1605, 8am  6pm EST Option 1 Product Complaints - 800-678-1605, 8am  5pm CST Option 3
Quantity in Commerce 24 units
Distribution U.S.: MO O.U.S.: None
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 = LPN and Original Applicant = ALLERGAN, INC.
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