Z-0948-2021Class II

REFRESH CONTACTS Contact Lens Comfort Drops 0.4 fl oz (12 mL) Sterile

Name: Z-0948-2021 REFRESH CONTACTS Contact Lens Comfort Drops 0.4 fl oz (12 mL) Sterile
Creator: Allergan PLC
Published: 2020-12-29
License: https://open.fda.gov/license/

Allergan / initiated 2020-12-29 / Terminated / root cause: manufacturing process

FDA source

Allergan PLC began a recall of REFRESH CONTACTS Contact Lens Comfort Drops 0.4 fl oz (12 mL) Sterile on 2020-12-29. FDA classified it as Class II and gives the reason as "Missing Instruction For Use insert". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0948-2021
Classification: Class II
Status: Terminated
Initiated: 2020-12-29
Posted: 2021-02-03
Terminated: 2023-03-23
Recalling firm: Allergan
Product: REFRESH CONTACTS Contact Lens Comfort Drops 0.4 fl oz (12 mL) Sterile
Product code: LPN Accessories, Soft Lens Products
Reason for recall: Missing Instruction For Use insert.
Root cause tag: manufacturing process
FDA 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 - [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
Quantity in commerce: 24 units
Distribution: U.S.: MO O.U.S.: None
Product codes and lots: Model Number: 91822US UDI Code: (01)00300231822120(17)230705(10)T0464A Lot Number: T0464A

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0948-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0948-2021	Class II	Terminated	Voluntary: Firm initiated	2021-02-10	2021-02-03

Product code LPN

K992028Class IIRefresh Contacts Lubricating and Rewetting DropsAllergan, Inc. / cleared 1999-10-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)