Device 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.
Z-0694-2020
Product summary
- Firm
- Tekia, Inc.
- Event
- Event 83903
- Status
- Terminated
- Classification
- Class II
- Quantity
- 81 IOLs were distributed but only 36 within expiry were recalled
- Official record key
device-enforcement:Z-0694-2020
Official wording
Reason: A limited number of lenses may be mislabeled with the incorrect diopter power.
Code information: 36 recalled serial numbers from Lot 522-003: U12220229, 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.
Distribution pattern: There was no U.S. distribution. Foreign distribution was made to Iran, Korea, Luxembourg, and Vietnam.
Derived failure modes
-
Labeling or packaging
mislabeled