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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