Medical device recalls Moderate risk

Johnson & Johnson Surgical Vision, Inc. recalls TECNIS Symfony, Extended Range of Vision IOL, REF: ZXR00, STERILE.EO, Rx Only

Recall date
July 6, 2023
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2288-2023
FDA classification
Class II
Brand / firm
Johnson & Johnson Surgical Vision, Inc.
Sold / distributed
International distribution to the countries of China, India, Korea.

Why it was recalled

Their is a potential that intraocular lenses (IOLs) were manufactured with unintended toric fiducial 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 Symfony, Extended Range of Vision IOL, REF: ZXR00, STERILE.EO, Rx Only

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