Medical device recalls Moderate risk

Johnson & Johnson Surgical Vision Inc recalls TECNIS Toric 1-Piece IOL, Model Number: ZCT150 +23.5D SE 1.50D CYL - Product Usage: intended to be placed in the capsul…

Recall date
January 27, 2021
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1163-2021
FDA classification
Class II
Brand / firm
Johnson & Johnson Surgical Vision Inc
Sold / distributed
U.S. Nationwide distribution in the states of AL, AZ, CA, FL, GA, IL, LA, MI, MN, NC, NY, OH, PA, SC, TN, TX, UT and WA.

Why it was recalled

Due to the release of nonconforming Intraocular Lenses (IOLs).

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 1-Piece IOL, Model Number: ZCT150 +23.5D SE 1.50D CYL - Product Usage: intended to be placed in the capsular bag.

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