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Recall Observatory FDA recall evidence

Device product

DeRoyal CATARACT PACK, REF 89-10040.01

Z-0714-2023

November 03, 2022

Class II

Product summary

Firm
DeRoyal Industries Inc
Event
Event 91134
Status
Ongoing
Classification
Class II
Quantity
108 kits
Official record key
device-enforcement:Z-0714-2023

Official wording

Reason: XXX

Code information: Lot Numbers: 56125881 exp 05/01/2026; 56618926 exp 05/01/2026; 57485029 exp 11/01/2026

Distribution pattern: US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    XXX