ClearanceBrief
Recall Z-1211-2018 ยท MVN Lens, Contact, (Disposable)

Johnson & Johnson Vision Care, Inc.

1-DAY ACUVUE Moist for ASTIGMATISM Brand Contact Lenses

DateOct 19, 2017
StatusTerminated
ReasonSome contact lenses were associated with complaints of a foreign matter caught between the blister package and foil.
Root causePackaging process control
ActionOn October 19, 2017, Johnson and Johnson sent letters to their customers stating the recall of ACUVUE and given the instructions to review their inventory, stop using the affected lots, use the enclosed label to return any affected products, contact customer service to arrange the return, even if they do not have any recall product inventory. A contact was provided to each individual letter.
Quantity56,070
DistributionWorldwide distribution. US nationwide including Puerto Rico, Korea, Czech Republic, China, Japan, Great Britain, Austria, Malaysia, Hong Kong, Russia, Taiwan, Singapore, India, and Brazil
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K051900ACUVUE (ETAFILCON A) CONTACT LENS, CLEAR AND WITH VISIBILITY TINT WITH UV BLOCKER, FOR DAILY WEAR
Johnson & Johnson Vision Care, Inc., Aug 12, 2005