Recall Z-1227-2020
CooperVision Inc. · initiated January 13, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Coopervision Vertex Toric /2 Clear Toric- Power -2.50 -0.75 /90 Soft (hydrophilic) Contact Lens (extended wear)
Codes / lots: Lot Numbers: 15627000009010 15627050004010 16656000008010
Reason for recall
Incorrect power of lenses than the expected
FDA-determined cause: Process control
Action taken
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.
Details
- Recall number
- Z-1227-2020
- Initiated
- January 13, 2020
- Posted by FDA
- January 27, 2020
- Terminated
- July 22, 2020
- Product code
- LPM – Lenses, Soft Contact, Extended Wear
- Quantity
- 216 units
- Distribution
- US Nationwide Distribution
- Recalling firm
- CooperVision Inc., West Henrietta, NY
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1228-2020 Class II | Coopervision Vertex Toric /2 Clear Toric- Power +2.25 -0.75/120 Soft (hydrophilic)…Incorrect power of lenses than the expected | 01/13/2020Terminated |