The Recall Desk
HighFDA (Devices)·Z-2916-2018·Announced 2018-08-29

Johnson & Johnson Recalls 1-Day ACUVUE MOIST Contact Lenses

Johnson & Johnson Vision Care is recalling specific lots of 1-Day ACUVUE MOIST contact lenses due to reports of partially formed lenses that appear smaller and stiffer.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a physical defect in a medical device (partially formed lenses) that poses a risk of harm to the eye, even though specific injury reports are not detailed in the provided text.

Plain-English summary

Johnson & Johnson Vision Care, Inc. is recalling specific lots of 1-Day ACUVUE MOIST Daily Wear contact lenses. The affected product is the 8.5 Base Curve, -3.25 Power version, repackaged in 30 and 90-packs. The recall involves a master lot containing 12 split lots, with a total of 195,660 units distributed worldwide, including the United States, Puerto Rico, Canada, Barbados, Japan, and Korea.

The recall was initiated after the company received reports of partially formed contact lenses. These defective lenses appear visibly smaller in diameter, feel thicker and stiffer to the touch, and are more darkly tinted blue than normal contact lenses. The product is intended for daily disposable wear for the optical correction of refractive ametropia in phakic or aphakic persons with non-diseased eyes.

Consumers should check their contact lens packaging for the specific lot numbers listed in the official recall notice. If the lot number matches the affected lots, consumers should stop using the product and contact Johnson & Johnson Vision Care for instructions on how to return the product or obtain a refund.

The recalled product

Product
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 p

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (13)

  • Master Lot Number 516191. 90 Pack Lot Number (US
  • PR
  • Canada
  • Barbados) 5165915104 which contains 30 pack lot numbers: 5165910104
  • 5165910105
  • 5165910106
  • 5165910107
  • 5165910108
  • 5165910111
  • 5165910102
  • 5165910103. Unique Device Identifier (UDI): 733905577215
  • 733905615078
  • and 733905888472.

Distribution

Distributed nationwide across the United States.

The notice also names 22 states specifically: