REFRESH CONTACTS Contact Lens Comfort Drops 0.4 fl oz (12… recallZ-0948-2021 · Allergan PLC · initiated Dec 29, 2020
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Allergan PLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Missing Instruction For Use insert.
FDA root cause category: Employee error
What the company is doing
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 - [email protected] 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
Recall details
- Recall number
- Z-0948-2021
- Status
- Terminated
- Initiated by the company
- Dec 29, 2020
- Recalling firm
- Allergan PLC
- Quantity
- 24 units
- Product code
- LPN
- FDA submissions
- K992028
- Distribution
- U.S.: MO O.U.S.: None
Product description
REFRESH CONTACTS Contact Lens Comfort Drops 0.4 fl oz (12 mL) Sterile
Code information (models, lots, serial numbers)
Model Number: 91822US UDI Code: (01)00300231822120(17)230705(10)T0464A Lot Number: T0464A
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- REFRESH CONTACTS® Contact Lens Comfort Drops 91822USAllergan, Inc. · Accessories, Soft Lens Products1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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