Medical device recalls Moderate risk

Tekia, Inc. recalls TEKIA Single Piece Hydrophilic Acrylic Intraocular Lenses, Model 811

Recall date
September 29, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0237-2016
FDA classification
Class II
Brand / firm
Tekia, Inc.
Sold / distributed
Internationally to Vietnam.

Why it was recalled

Tekia is recalling the Single Piece Hydrophillic Acrylic Intraocular Lenses (IOLs) because they may be labeled with the incorrect diopter power.

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

What was recalled

TEKIA Single Piece Hydrophilic Acrylic Intraocular Lenses, Model 811

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