Z-0694-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- December 25, 2019
- Initiation Date
- November 9, 2018
- Termination Date
- September 16, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 81 IOLs were distributed but only 36 within expiry were recalled
Product Description
TEKIA Model 872 Single Piece Hydrophilic Acrylic Intraocular Lenses, Diopter 15.0, Sterile. The firm name on the label is TEKIA, INC., Irvine, CA.
Reason for Recall
A limited number of lenses may be mislabeled with the incorrect diopter power.
Distribution Pattern
There was no U.S. distribution. Foreign distribution was made to Iran, Korea, Luxembourg, and Vietnam.
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.