CLASS II Device recall · Reported 29 Aug 2018 · FDA Enforcement Report

1-Day Acuvue Moist Daily Wear, 8.5 Base Curve, -3.25 Power recalled

Johnson & Johnson Vision Care is recalling 1-Day Acuvue Moist Daily Wear, 8.5 Base Curve, -3.25 Power, distributed nationwide in the US. The recall was initiated on 23 Jul 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesMaster Lot Number 516191. 90 Pack Lot Number (US, PR, Canada, Barbados) 5165915104 which contains 30 pack lot numbers: 5165910104, 5165910105, 5165910106, 5165910107, 5165910108, 5165910109. 90 Pack Lot Number (Japan) 5165915110 which contains 30 pack lot numbers: 5165910110, 5165910111, 5165910112. 90 Pack Lot Number (Korea and Japan) 5165915101 which contains 30 pack lot numbers: 5165910101, 5165910102, 5165910103. Unique Device Identifier (UDI): 733905577215, 733905615078, and 733905888472.

Quantity recalled195,660 Total; 89,640 US & Puerto Rico, 106,020 OUS

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-2916-2018
FDA event ID: 80654
Recalling firm: Johnson & Johnson Vision Care, Jacksonville, FL
Classification: Class II
Status: Terminated
Recall initiated: 23 Jul 2018
FDA classified: 23 Aug 2018
Reported: 29 Aug 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

23 Jul 2018	Recall initiated by company
23 Aug 2018	Classified by FDA	+31 days
29 Aug 2018	Published in enforcement report	+6 days

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

Reason for recall

Johnson and Johnson Vision Care received a number of reports of a partially formed contact lens, which appears to the customer or consumer as visibly smaller in diameter, thicker/stiffer to the touch and more darkly tinted blue than the normal contact lens.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

Johnson and Johnson Vision Care 1-Day ACUVUE MOIST Daily Wear, 8.5 Base Curve, -3.25 Power. Master Lot, containing 12 split lots, repackaged in 30 and 90-packs . Intended for daily disposable wear for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who may have 1.00D or less of astigmatism.

Where it was distributed

Worldwide distribution: US (Nationwide) distribution to CA, CT, FL, GA, IA, IL, MA, MD, ME, MO, NC, NE, NH, NJ, NY, OH, PA, TN, TX, UT, and VA, Puerto Rico; and countries of: Canada, Barbados, Japan, and Korea.

Nationwide California Connecticut Florida Georgia Iowa Illinois Massachusetts Maryland Maine Missouri North Carolina Nebraska New Hampshire New Jersey New York Ohio Pennsylvania Puerto Rico Tennessee Texas

Questions about this recall

Why was it recalled?

Which lots are affected?

Master Lot Number 516191. 90 Pack Lot Number (US, PR, Canada, Barbados) 5165915104 which contains 30 pack lot numbers: 5165910104, 5165910105, 5165910106, 5165910107, 5165910108, 5165910109. 90 Pack Lot Number (Japan) 5165915110 which contains 30 pack lot numbers: 5165910110, 5165910111, 5165910112. 90 Pack Lot Number (Korea and Japan) 5165915101 which contains 30 pack lot numbers: 5165910101, 5165910102, 5165910103. Unique Device Identifier (UDI): 733905577215, 733905615078, and 733905888472.

Where was it sold?

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 Johnson & Johnson Vision Care

All 10

Reported	Class	Recall	Company	Reason	Where
30 Jul 2025Device	CLASS II	Acuvue¿ Oasys Max 1-Day Multifocal recalled	Johnson & Johnson Vision Care	Device Malfunction	Nationwide
23 Jun 2021Device	CLASS II	Acuvue Vita soft (hydrophilic) contact lens (spherical) recalled	Johnson & Johnson Vision Care	Packaging Defects	Nationwide
29 Apr 2020Device	CLASS II	Acuvue Oasys for Astigmatism Contact Lenses recalled	Johnson & Johnson Vision Care	Packaging Defects	Nationwide
17 Apr 2019Device	CLASS II	Acuvue Oasys for Astigmatism contact lenses recalled	Johnson & Johnson Vision Care	Packaging Defects	CA
4 Apr 2018Device	CLASS II	1-Day Acuvue Moist for Astigmatism Contact Lenses recalled	Johnson & Johnson Vision Care	Foreign Material	Nationwide

Other Other Medical Devices recalls

All 13,950

Reported	Class	Recall	Company	Reason	Where
28 Oct 2026Device	CLASS II	Medline Drape C-section W/Pouch ST 7/CS, Medline Product Number recalled	Medline Industries	Other	Nationwide
28 Oct 2026Device	CLASS II	Medline medical convenience kits labeled as recalled	Medline Industries	Other	Nationwide
28 Oct 2026Device	CLASS II	Medline medical convenience kits labeled as: Fetal Surgery Cds-lf recalled	Medline Industries	Other	Nationwide
28 Oct 2026Device	CLASS II	Medline Drape C-section Fen Clr Screen W, Medline Product Number recalled	Medline Industries	Other	Nationwide
28 Oct 2026Device	CLASS II	Medline medical convenience kits labeled as: C-section Pack recalled	Medline Industries	Other	Nationwide