TECNIS Toric II OptiBlue IOL Models ZCW
FDA Recall #Z-0735-2024 — Class II — December 12, 2023
Product Description
TECNIS Toric II OptiBlue IOL Models ZCW
Reason for Recall
Due to intraocular lens containing an angle out of specification (OOS). The cylinder axis marks do not meet product specifications for the allowable angle between Low Power Meridian (LPM) and toric cylinder axis marks.
Recalling Firm
Johnson & Johnson Surgical Vision, Inc. — Irvine, CA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
36
Distribution
International distribution to the country of Japan.
Code Information
Model Numbers: ZCW375 UDI code: N/A (not distributed in the U.S.) Serial Numbers: 3473902107 3473912107 3473922107 3473932107 3473942107 3473952107 3473962107 3473972107 3474002107 3474012107 3474022107 3474072107 3474082107 3474092107 3474102107 3474112107 3474122107 3474132107 3474152107 3474162107 3474172107 3474182107 3474192107 3474202107 3474222107 3474232107 3474242107 3474252107 3474262107 3474282107 3474292107 3474312107 3474322107 3474332107 3474342107 3474352107
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated