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

FDA Recall #Z-0948-2021 — Class II — December 29, 2020

Recall #Z-0948-2021 Date: December 29, 2020 Classification: Class II Status: Terminated

Product Description

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

Reason for Recall

Missing Instruction For Use insert.

Recalling Firm

Allergan PLC — Irvine, CA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

24 units

Distribution

U.S.: MO O.U.S.: None

Code Information

Model Number: 91822US UDI Code: (01)00300231822120(17)230705(10)T0464A Lot Number: T0464A

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated