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U.S. Department of Health and Human Services

Class 2 Device Recall The Vertex Toric / 2 Clear Toric (methafilcon A) Soft (hydrophilic) contact lenses

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 Class 2 Device Recall The Vertex Toric / 2 Clear Toric (methafilcon A) Soft (hydrophilic) contact lensessee related information
Date Initiated by FirmJanuary 13, 2020
Date PostedJanuary 27, 2020
Recall Status1 Terminated 3 on July 22, 2020
Recall NumberZ-1227-2020
Recall Event ID 84725
PMA NumberP850079 
Product Classification Lenses, soft contact, extended wear - Product Code LPM
ProductCoopervision Vertex Toric /2 Clear Toric- Power -2.50 -0.75 /90 Soft (hydrophilic) Contact Lens (extended wear)
Code Information Lot Numbers:  15627000009010 15627050004010 16656000008010
Recalling Firm/
Manufacturer		 CooperVision Inc.
180 Thruway Park Dr
West Henrietta NY 14586-9798
For Additional Information ContactSAME
585-756-9300
Manufacturer Reason
for Recall		Incorrect power of lenses than the expected
FDA Determined
Cause 2		Process control
ActionCooperVision 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 in Commerce216 units
DistributionUS Nationwide Distribution
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA DatabasePMAs with Product Code = LPM
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