Device product
ACUVUE ADVANCE Brand Contact Lenses with HYDRACLEAR
Z-1210-2018
Product summary
- Event
- Event 79152
- Status
- Terminated
- Classification
- Class II
- Quantity
- 165,750
- Official record key
device-enforcement:Z-1210-2018
Official wording
Reason: Some contact lenses were associated with complaints of a foreign matter caught between the blister package and foil.
Code information: Lot B00DHLP Exp. 08/2018 Base Curve 8.7, Refractive Power -10.00D - Manufactured in J&J Vision Care Inc. Jacksonville, FL Lot L002FNL Exp. 07/2020 Base Curve 8.7 Refractive Power -4.75D Manufactured in J&J Vision Care Ireland Lot L002V94 Exp. 01/2022 Base Curve 8.7 Refractive Power -5.00D
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