Z-1210-2018 Class II Terminated
FDA device recall Z-1210-2018 was initiated by Johnson & Johnson Vision Care, Inc. on October 19, 2017 and is designated Class II. Reason for recall: Some contact lenses were associated with complaints of a foreign matter caught between the blister package and foil. The recall status is terminated (terminated June 12, 2020). Affected quantity: 165,750.
Recall Details
- Product Type
- Devices
- Report Date
- April 4, 2018
- Initiation Date
- October 19, 2017
- Termination Date
- June 12, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 165,750
Product Description
ACUVUE ADVANCE Brand Contact Lenses with HYDRACLEAR
Reason for Recall
Some contact lenses were associated with complaints of a foreign matter caught between the blister package and foil.
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
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