DeRoyal CATARACT PACK, REF 89-10040.01
FDA Recall #Z-0714-2023 — Class II — November 3, 2022
Product Description
DeRoyal CATARACT PACK, REF 89-10040.01
Reason for Recall
XXX
Recalling Firm
DeRoyal Industries Inc — Powell, TN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
108 kits
Distribution
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
Code Information
Lot Numbers: 56125881 exp 05/01/2026; 56618926 exp 05/01/2026; 57485029 exp 11/01/2026
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.