Device product
1-DAY ACUVUE Moist for ASTIGMATISM Brand Contact Lenses
Z-1211-2018
Product summary
- Event
- Event 79152
- Status
- Terminated
- Classification
- Class II
- Quantity
- 56,070
- Official record key
device-enforcement:Z-1211-2018
Official wording
Reason: Some contact lenses were associated with complaints of a foreign matter caught between the blister package and foil.
Code information: 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
Distribution pattern: Worldwide distribution. US nationwide including Puerto Rico, Korea, Czech Republic, China, Japan, Great Britain, Austria, Malaysia, Hong Kong, Russia, Taiwan, Singapore, India, and Brazil
Derived failure modes
-
Foreign material or chemical contamination
foreign matter