Tekia, Inc.: Medical Device Recall in 2019 - (Recall #: Z-0694-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: November 9, 2018

Date Posted: December 25, 2019

Recall Number: Z-0694-2020

Event ID: 83903

Reason for Recall:

A limited number of lenses may be mislabeled with the incorrect diopter power.

Status: Terminated

Product Quantity: 81 IOLs were distributed but only 36 within expiry were recalled

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.

Voluntary or Mandated:

Voluntary: Firm initiated