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Recall Observatory FDA recall evidence

Device product

SPECSAVERS UMERE TORIC Power -07.00 -1.25/180 Daily Disposable Contact Lens with UV blocker

Z-2148-2021

May 19, 2021

Class II

Product summary

Firm
CooperVision Inc.
Event
Event 88096
Status
Terminated
Classification
Class II
Quantity
60 lenses
Official record key
device-enforcement:Z-2148-2021

Official wording

Reason: Misaligned placement of an axis mark can cause the patient to experience blurred vision

Code information: Lot Number: U0108940

Distribution pattern: Worldwide distribution - US Nationwide distribution in the states of FL, NY, TN, OH, NC, WI and the countries of France, United Arab Emirates, Brazil, Australia, New Zealand, Taiwan, Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Misaligned placement of an axis mark can cause the patient to experience blurred vision