Home / Recalls / Johnson & Johnson Vision Care, Inc. / Z-2916-2018

Z-2916-2018 Class II Terminated

Recalled by Johnson & Johnson Vision Care, Inc. — Jacksonville, FL

Recall Details

Product Type
Devices
Report Date
August 29, 2018
Initiation Date
July 23, 2018
Termination Date
December 6, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
195,660 Total; 89,640 US & Puerto Rico, 106,020 OUS

Product Description

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.

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.

Distribution Pattern

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.

Code Information

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.

Other recalls by Johnson & Johnson Vision Care, Inc.

  • Z-2163-2025 Class II — ACUVUE¿ OASYS MAX 1-Day MULTIFOCAL (June 12, 2025)
  • Z-1865-2021 Class II — ACUVUE VITA soft (hydrophilic) contact lens (spherical) for daily wear. Base Cu (May 6, 2021)
  • Z-1131-2019 Class II — ACUVUE OASYS for ASTIGMATISM brand contact lenses, Base Curve 8.6 Refractive Pow (March 11, 2019)
  • Z-1744-2020 Class II — ACUVUE OASYS for ASTIGMATISM Brand Contact Lenses. Lot no. B00NKM0G. Base Curve (December 18, 2017)
  • Z-1211-2018 Class II — 1-DAY ACUVUE Moist for ASTIGMATISM Brand Contact Lenses (October 19, 2017)
  • Z-1209-2018 Class II — ACUVUE OASYS Brand Contact Lenses with HYDRACLEAR PLUS (October 19, 2017)
  • Z-1210-2018 Class II — ACUVUE ADVANCE Brand Contact Lenses with HYDRACLEAR (October 19, 2017)
  • Z-1335-2013 Class II — 1-DAY ACUVUE MOIST Brand Contact Lenses, soft disposable contact lenses. The (December 21, 2012)
  • Z-1336-2013 Class II — ACUVUE ADVANCE Brand Contact Lenses with HYDRACLEAR, Soft, disposable contact le (December 21, 2012)