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Terminated

Coopervision Vertex Toric /2 Clear Toric- Power -2.50 -0.75 /90 Soft (hydrophilic) Contact Lens (extended wear)

FDA Recall Z-1227-2020 · Posted 2020-01-27

Recalling FirmCooperVision Inc.
Recall StatusTerminated
Product CodeLPM
Date Initiated2020-01-13
Date Terminated2020-07-22
Product Quantity216 units

Reason for Recall

Incorrect power of lenses than the expected

Firm 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.

Root Cause

Process control

Distribution Pattern

US Nationwide Distribution

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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