Recall Z-0948-2021 ยท LPN Accessories, Soft Lens Products
Allergan PLC
REFRESH CONTACTS Contact Lens Comfort Drops 0.4 fl oz (12 mL) Sterile
| Date | Dec 29, 2020 |
| Status | Terminated |
| Reason | Missing Instruction For Use insert. |
| Root cause | Employee error |
| Action | On 12/29/2020, the firm sent an "URGENT DEVICE RECALL" to customers via overnight tracked mail informing them the affected lot is missing the instructions for use and safety information referenced on the carton. Customers are instructed to: 1. Quarantine the product that they have in their inventory 2. Carry out a physical count of the affected product and record the count on the enclosed Business Response Form (BRF). 3. Send the BRF to the Recalling Firm via email within five (5) business days of receipt. To ensure that the Recalling Firm is able to account for all recalled product, it is i |
| Quantity | 24 units |
| Distribution | U.S.: MO O.U.S.: None |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K992028 | REFRESH CONTACTS LUBRICATING AND REWETTING DROPS Allergan, Inc., Oct 7, 1999 |