The Recall Desk
ModerateFDA (Devices)·Z-0948-2021·Announced 2021-02-10

Allergan Recalls Refresh Contacts Comfort Drops Due to Missing Instructions

Allergan PLC is recalling Refresh Contacts Contact Lens Comfort Drops because the packages are missing the Instruction For Use insert. Consumers should stop using the product and contact the manufacturer.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is for a missing Instruction For Use insert, which is a documentation issue. According to the rubric, documentation issues and packaging-only problems are typically classified as Low or Moderate severity. Since it is an FDA Class II recall, it is not a Class III (unlikely to cause adverse health consequences), but the hazard is administrative rather than a direct physical safety risk like contamination or injury.

Plain-English summary

Allergan PLC is recalling Refresh Contacts Contact Lens Comfort Drops 0.4 fl oz (12 mL) Sterile. The recall was initiated because the product packages are missing the Instruction For Use insert. The affected product is identified by Model Number 91822US, UDI Code (01)00300231822120(17)230705(10)T0464A, and Lot Number T0464A.

The recall involves 24 units of the product. Distribution was limited to the state of Missouri. No other states or countries are listed in the distribution pattern.

Consumers who have this product should stop using it and contact Allergan PLC for further instructions. The recall is classified as Class II by the FDA.

The recalled product

Product
REFRESH CONTACTS¿ Contact Lens Comfort Drops 0.4 fl oz (12 mL) Sterile
Manufacturer
Allergan PLC
Affected units
24

Distribution

Distributed in 1 state: