Recall Z-1209-2018 ยท LPM Lenses, Soft Contact, Extended Wear
Johnson & Johnson Vision Care, Inc.
ACUVUE OASYS Brand Contact Lenses with HYDRACLEAR PLUS
| Date | Oct 19, 2017 |
| Status | Terminated |
| Reason | Some contact lenses were associated with complaints of a foreign matter caught between the blister package and foil. |
| 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 | 125,763 |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042275 | VISTAKON (SENOFILCON A) SOFT CONTACT LENS Vistakon, Oct 28, 2004 |