ACUVUE OASYS Brand Contact Lenses with HYDRACLEAR PLUS
This recall has been terminated (originally issued October 19, 2017).
- Recall Initiated
- October 19, 2017
- Terminated
- June 12, 2020
- Recall Number
- Z-1209-2018
- Quantity
- 125,763
- Firm Location
- Jacksonville, FL
- Official Source
- View on FDA website ↗
Reason for Recall
Some contact lenses were associated with complaints of a foreign matter caught between the blister package and foil.
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
Lot / Code Info
Lot L002NCS exp. 05/2020 base Curve 8.8 Refractive Power -4.00D and Lot L002QH9 exp. 08/2020 Base Curve 8.8 Refractive Power -4.50D Manufactured at J&J Vision Care Ireland
Root Cause
Packaging process control
Action Taken
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.