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Recall Observatory FDA recall evidence

Device product

GEO-MED CATARACT PACK, REF 89-5790.08

Z-0709-2023

November 03, 2022

Class II

Product summary

Firm
DeRoyal Industries Inc
Event
Event 91134
Status
Ongoing
Classification
Class II
Quantity
834 kits
Official record key
device-enforcement:Z-0709-2023

Official wording

Reason: XXX

Code information: Lot Numbers: 55966890 exp 02/01/2023; 56020131 exp 03/01/2023; 56184435 exp 02/01/2023; 56618387 exp 06/01/2023; 57001493 exp 06/01/2023; 57227821 exp 09/01/2023; 57466709 exp 09/01/2023; 57589522 exp 09/01/2023; 57749750 exp 12/01/2023; 5786389 ezp 12/01/2023

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