Atlas FDA

Coopervision Vertex Toric /2 Clear Toric- Power +2.25 -0.75/120 Soft (hydrophilic) Contact Lens (extended wear)

FDA device recall Z-1228-2020 · posted 2020-01-27 · Terminated

Recall details

Recalling firm
CooperVision Inc.
Reason for recall
Incorrect power of lenses than the expected
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.
Root cause
Process control
Status
Terminated
Product code
LPM
Quantity affected
24
Distribution
US Nationwide Distribution
Date initiated
2020-01-13
Date posted
2020-01-27
Date terminated
2020-07-22
Location
West Henrietta, NY

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