Date Initiated by Firm |
January 13, 2020 |
Date Posted |
January 27, 2020 |
Recall Status1 |
Terminated 3 on July 22, 2020 |
Recall Number |
Z-1227-2020 |
Recall Event ID |
84725 |
PMA Number |
P850079 |
Product Classification |
Lenses, soft contact, extended wear - Product Code LPM
|
Product |
Coopervision 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 Contact |
SAME 585-756-9300
|
Manufacturer Reason for Recall |
Incorrect power of lenses than the expected
|
FDA Determined Cause 2 |
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 in Commerce |
216 units |
Distribution |
US Nationwide Distribution |
Total Product Life Cycle |
TPLC Device Report
|
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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.
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PMA Database |
PMAs with Product Code = LPM and Original Applicant = COOPERVISION, INC.
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