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Recall Observatory FDA recall evidence

Device product

Soft Contact Lens

Z-0529-2015

October 28, 2014

Class II

Product summary

Firm
Cooper Vision Caribbean Corp.
Event
Event 69496
Status
Terminated
Classification
Class II
Quantity
1170
Official record key
device-enforcement:Z-0529-2015

Official wording

Reason: Portions of the lots may contain units with an incorrect lens axis condition.

Code information: Lots # 8246525202 & 8255525096

Distribution pattern: US Nationwide Distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Portions of the lots may contain units with an incorrect lens axis condition.