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Recall Observatory FDA recall evidence

Device product

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

Z-0948-2021

December 29, 2020

Class II

Product summary

Firm
Allergan PLC
Event
Event 87058
Status
Terminated
Classification
Class II
Quantity
24 units
Official record key
device-enforcement:Z-0948-2021

Official wording

Reason: Missing Instruction For Use insert.

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

Distribution pattern: U.S.: MO O.U.S.: None

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Missing Instruction For Use insert.