Johnson & Johnson Vision Care, Inc.: Medical Device Recall in 2018 - (Recall #: Z-2916-2018)
See the recall detail below. You can also see other recalls from the same firm in 2018.
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.
Class II
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.
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.
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.
Voluntary: Firm initiated