Recall Z-0694-2020— Tekia, Inc.

Name: FDA recall Z-0694-2020
Creator: U.S. Food and Drug Administration
Published: 2018-11-09

Class II · Terminated

Class II FDA medical device recall by Tekia, Inc., initiated 2018-11-09, terminated 2020-09-16. FDA's recall record names no specific 510(k) clearance for this event. Product: TEKIA Model 872 Single Piece Hydrophilic Acrylic Intraocular Lenses, Diopter 15.0, Sterile. The firm name on the label is TEKIA, INC., Irvine, CA.. Reason: A limited number of lenses may be mislabeled with the incorrect diopter power..

Recalling firm: Tekia, Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-11-09
Terminated: 2020-09-16
Firm location: Irvine, CA, United States

Product description

TEKIA Model 872 Single Piece Hydrophilic Acrylic Intraocular Lenses, Diopter 15.0, Sterile. The firm name on the label is TEKIA, INC., Irvine, CA.

Reason for recall

A limited number of lenses may be mislabeled with the incorrect diopter power.

Data sourced from openFDA. This site is unofficial and independent of the FDA.