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Recall Observatory FDA recall evidence

Device product

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

Z-1228-2020

January 13, 2020

Class II

Product summary

Firm
CooperVision Inc.
Event
Event 84725
Status
Terminated
Classification
Class II
Quantity
24
Official record key
device-enforcement:Z-1228-2020

Official wording

Reason: Incorrect power of lenses than the expected

Code information: Lot Numbers: 15628000006509 15628000007509

Distribution pattern: US Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Incorrect power of lenses than the expected