TEKIA Single Piece Hydrophilic Acrylic Intraocular Lenses recalled over labeling errors

Recall date

November 9, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Tekia, Inc. recalls TEKIA Model 872 Single Piece Hydrophilic Acrylic Intraocular Lenses, Diopter 15.0, Sterile. The firm name on the label…

Recall number

Z-0694-2020

FDA classification

Class II

Brand / firm

Tekia, Inc.

Sold / distributed

There was no U.S. distribution. Foreign distribution was made to Iran, Korea, Luxembourg, and Vietnam.

Why it was recalled

A limited number of lenses may be mislabeled 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 Model 872 Single Piece Hydrophilic Acrylic Intraocular Lenses, Diopter 15.0, Sterile. The firm name on the label is TEKIA, INC., Irvine, CA.