FDA Medical Device Recalls (openFDA)
Allergan PLC: REFRESH CONTACTS Contact Lens Comfort Drops 0.4 fl oz (12 mL) Sterile
- Recall number
- Z-0948-2021
- Recalling firm
- Allergan PLC
- Product
- REFRESH CONTACTS Contact Lens Comfort Drops 0.4 fl oz (12 mL) Sterile
- Status
- Terminated
- Initiated
- 2020-12-29
- Posted
- not on file
- Terminated
- 2023-03-23
- Reason
- Missing Instruction For Use insert.
- Root cause
- 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
- 24 units
- Distribution
- U.S.: MO O.U.S.: None
- Lot, serial or model codes
- Model Number: 91822US UDI Code: (01)00300231822120(17)230705(10)T0464A Lot Number: T0464A
- 510(k) numbers
- ["K992028"]
- PMA numbers
- not on file
- Product code
- LPN
- Firm FEI
- 2011068
- Firm city
- Irvine
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28