Recall Z-1228-2020 ยท LPM Lenses, Soft Contact, Extended Wear
CooperVision Inc.
Coopervision Vertex Toric /2 Clear Toric- Power +2.25 -0.75/120 Soft (hydrophilic) Contact Lens (extended wear)
| Date | Jan 27, 2020 (initiated Jan 13, 2020) |
| Status | Terminated |
| Reason | Incorrect power of lenses than the expected |
| Root cause | Process control |
| Action | CooperVision issued Device Correction letter dated 1/20/19, stating reason for recall, health risk and action to take: Examine your inventory for the impacted lot numbers on the enclosed Ship Report. " Stop any further distribution of the specified lots of Vertex Toric and 2 Clear Toric lenses as appropriate. " Please discard product and contact CooperVision, Customer Service department at 1-800-340-2020 to receive credit and/or complimentary replacement product. Questions contact CooperVision Customer Service at 1-800-341-2020, 9:00 AM 7:00 PM ET, Monday Friday. |
| Quantity | 24 |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.