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Tekia, Inc. recalls TEKIA Model 872 Single Piece Hydrophilic Acrylic Intraocular Lenses, Diopter 15.0, Sterile. The firm name on the label
Recalled December 25, 2019 · FDA recall Z-0694-2020 · Tekia
Hazard
A limited number of lenses may be mislabeled with the incorrect diopter power. · FDA Class II
Units
81 IOLs were distributed but only 36 within expiry were recalled
Sold at
There was no U.S. distribution. Foreign distribution was made to Iran, Korea, Luxembourg, and Vietnam.
Description
A limited number of lenses may be mislabeled with the incorrect diopter power.
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.
Manufacturer(s)
Tekia, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →