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| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1209-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1210-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1211-2018 | Class II | Terminated | Voluntary: Firm initiated |
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