FDA-Device2019-12-25Class II
TEKIA Model 872 Single Piece Hydrophilic Acrylic Intraocular Lenses, Diopter 15.0, Sterile. The firm name on the label is TEKIA, INC., Irvine, CA.
Tekia, Inc.
Hazard
A limited number of lenses may be mislabeled with the incorrect diopter power.
Sold states
There was no U.S. distribution. Foreign distribution was made to Iran, Korea, Luxembourg, and Vietnam.
Affected count
81 IOLs were distributed but only 36 within expiry were recalled
Manufactured in
17 Hammond Ste 414, Irvine, CA, United States
Products
TEKIA Model 872 Single Piece Hydrophilic Acrylic Intraocular Lenses, Diopter 15.0, Sterile. The firm name on the label is TEKIA, INC., Irvine, CA.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0694-2020Don't want to check this manually?
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