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Recall Observatory FDA recall evidence

Device product

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

Z-1227-2020

January 13, 2020

Class II

Product summary

Firm
CooperVision Inc.
Event
Event 84725
Status
Terminated
Classification
Class II
Quantity
216 units
Official record key
device-enforcement:Z-1227-2020

Official wording

Reason: Incorrect power of lenses than the expected

Code information: Lot Numbers: 15627000009010 15627050004010 16656000008010

Distribution pattern: US Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Incorrect power of lenses than the expected