Medical device recalls Moderate risk

Johnson & Johnson Surgical Vision, Inc. recalls TECNIS Toric II OptiBlue IOL Models ZCW

Recall date
December 12, 2023
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0735-2024
FDA classification
Class II
Brand / firm
Johnson & Johnson Surgical Vision, Inc.
Sold / distributed
International distribution to the country of Japan.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

TECNIS Toric II OptiBlue IOL Models ZCW

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