Reported Dec 25, 2019 · Terminated
TEKIA Model 872 Single Piece Hydrophilic Acrylic Intraocular Lenses, Diopter 15.0, Sterile. The firm name on the label…
Tekia, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Tekia, Inc. · 17 Hammond Ste 414 · Irvine, CA · 92618-1635
Is this the product you have?
- TEKIA Model 872 Single Piece Hydrophilic Acrylic Intraocular Lenses, Diopter 15.0, Sterile. The firm name on the label is TEKIA, INC., Irvine, CA.
- Lot codes and dates
- 36 recalled
- serial numbers from Lot 522-003U12220229, U12220230, U12220231, U12220232, U12220233, U12220234, U12220235, U12220236, U12220237, V01110221, V01110222, V01110223, V01110224, V02200066, V02200067, V02200068, V02200069, V02200070, V02200071, V03190037, V03190038, V04090143, V04090144, V04090145, V04090146, V04090147, V04090148, V04090149, V04090150, V04090151, V04090152, V01080056, V01080057, V03290055, V03290056, and V05020831. The remaining 45 IOL serial numbers were past expiry and not recalled
- Amount recalled
- 81 IOLs were distributed but only 36 within expiry were recalled
Why it was recalled
A limited number of lenses may be mislabeled with the incorrect diopter power.
This product could cause temporary or reversible health problems — stop using it.
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