CLASS II Device recall · Reported 10 Feb 2021 · FDA Enforcement Report

Refresh Contacts¿ Contact Lens Comfort Drops Sterile recalled

Allergan is recalling Refresh Contacts¿ Contact Lens Comfort Drops Sterile, distributed in Missouri. The recall was initiated on 29 Dec 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel Number: 91822US UDI Code: (01)00300231822120(17)230705(10)T0464A Lot Number: T0464A

Quantity recalled24 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0948-2021
FDA event ID: 87058
Recalling firm: Allergan, Irvine, CA
Classification: Class II
Status: Terminated
Recall initiated: 29 Dec 2020
FDA classified: 3 Feb 2021
Reported: 10 Feb 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Contact Lenses & Eye Devices

Timeline

29 Dec 2020	Recall initiated by company
3 Feb 2021	Classified by FDA	+36 days
10 Feb 2021	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Missing Instruction For Use insert.

Product as listed by the FDA

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

Where it was distributed

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

Missouri

Questions about this recall

Why was it recalled?

Missing Instruction For Use insert.

Which lots are affected?

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

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Allergan

All 29

Reported	Class	Recall	Company	Reason	Where
27 Jan 2021Drug	CLASS II	Refresh Relieva PF Preservative-Free Lubricant Eye Drops Sterile recalledRefresh Relieva Preservative Free	Allergan	Other	Nationwide
5 Aug 2020Drug	CLASS III	Skin Medica Acne Treatment Lotion (Benzoyl Peroxide 2.5%) recalled	Allergan	Potency & Assay	Nationwide
5 Aug 2020Drug	CLASS III	Skin Medica Acne System, Contains: Purifying Foaming Wash recalled	Allergan	Potency & Assay	Nationwide
11 Dec 2019Device	CLASS II	XEN Gel Stent recalled by Allergan	Allergan	Sterility	Nationwide
18 Sep 2019Device	CLASS I	Ritz Princess, Biocell, Intrashiel recalled by Allergan	Allergan	Foreign Material	Nationwide

Other Contact Lenses & Eye Devices recalls

All 153

Reported	Class	Recall	Company	Reason	Where
30 Sep 2026Device	CLASS II	Pearle Vision 1 day (somofilcon A) Contact Lens recalled by CooperVision	CooperVision	Other	Nationwide
1 Apr 2026Device	CLASS II	Tecnis Eyhance Iol with Tecnis Simplicity" Delivery System recalled	AMO Puerto Rico Manufacturing	Device Malfunction	Nationwide
5 Nov 2025Device	CLASS II	Alcon PRECISION1 One-Day Contact Lenses, -2.25D recalled	Alcon Research	Sterility	19 states
1 Oct 2025Device	CLASS II	Sofmed Breathables, (stenfilcon A) contact lens recalled by CooperVision	CooperVision	Sterility	Nationwide
1 Oct 2025Device	CLASS II	Voyant 1-Day Premium Toric, (stenfilcon A) contact lens recalled	CooperVision	Sterility	Nationwide