Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1211-2018Class II

1-DAY ACUVUE Moist for ASTIGMATISM Brand Contact Lenses

Johnson & Johnson Vision Care, Inc. / initiated 2017-10-19 / Terminated / root cause: packaging

Johnson & Johnson Vision Care, Inc. began a recall of 1-DAY ACUVUE Moist for ASTIGMATISM Brand Contact Lenses on . FDA classified it as Class II and gives the reason as "Some contact lenses were associated with complaints of a foreign matter caught between the blister package and foil". As of , the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number
Z-1211-2018
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Johnson & Johnson Vision Care, Inc.
Product
1-DAY ACUVUE Moist for ASTIGMATISM Brand Contact Lenses
Product code
MVN Lens, Contact, (Disposable)
Reason for recall
Some contact lenses were associated with complaints of a foreign matter caught between the blister package and foil.
Root cause tag
packaging
FDA root cause
Packaging process control
Action
On 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.
Quantity in commerce
56,070
Distribution
Worldwide distribution. US nationwide including Puerto Rico, Korea, Czech Republic, China, Japan, Great Britain, Austria, Malaysia, Hong Kong, Russia, Taiwan, Singapore, India, and Brazil
Product codes and lots
Lot B00LF41 Exp. 04/2021 Base Curve 8.5 Refractive Power -7.50D -1.25/180 Manufactured at J&J Vision Care Inc. Jacksonville, FL

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1211-2018
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1209-2018Class IITerminatedVoluntary: Firm initiated
Z-1210-2018Class IITerminatedVoluntary: Firm initiated
Z-1211-2018Class IITerminatedVoluntary: Firm initiated