Z-0694-2020 Class II Terminated
FDA device recall Z-0694-2020 was initiated by Tekia, Inc. on November 9, 2018 and is designated Class II. Reason for recall: A limited number of lenses may be mislabeled with the incorrect diopter power. The recall status is terminated (terminated September 16, 2020). Affected quantity: 81 IOLs were distributed but only 36 within expiry were recalled.
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.