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GEO-MED CATARACT PACK, REF 89-5790.08

FDA Recall #Z-0709-2023 — Class II — November 3, 2022

Recall #Z-0709-2023 Date: November 3, 2022 Classification: Class II Status: Ongoing

Product Description

GEO-MED CATARACT PACK, REF 89-5790.08

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

834 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: 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

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.

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