Recall Z-0948-2021— Allergan PLC

Name: FDA recall Z-0948-2021
Creator: U.S. Food and Drug Administration
Published: 2020-12-29

Class II · Terminated

Class II FDA medical device recall by Allergan PLC, initiated 2020-12-29, terminated 2023-03-23. It names one FDA 510(k) clearance: K992028. Product: REFRESH CONTACTS¿ Contact Lens Comfort Drops 0.4 fl oz (12 mL) Sterile. Reason: Missing Instruction For Use insert..

Recalling firm: Allergan PLC
Classification: Class II
Status: Terminated
Initiated: 2020-12-29
Terminated: 2023-03-23
Firm location: Irvine, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K992028 — REFRESH CONTACTS LUBRICATING AND REWETTING DROPSAllergan, Inc.·cleared 1999-10-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

Missing Instruction For Use insert.

Data sourced from openFDA. This site is unofficial and independent of the FDA.