Data Foundry

Medical device recalls 2019

TEKIA Model 872 Single Piece Hydrophilic Acrylic Intraocular Lenses — Class II medical device recall Z-0694-2020

Terminated recall by Tekia, Inc., reported 2019-12-25. A limited number of lenses may be mislabeled with the incorrect diopter power.

Recall numberZ-0694-2020
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmTekia, Inc., Irvine, CA, United States
Recall initiated2018-11-09
Classified2019-12-17
Reported by FDA2019-12-25
Terminated2020-09-16
Countries outside the USIR, KR, LU, VN
Reason classeslabeling
Lot numbers522-003, U12220229, U12220230, U12220231, U12220232, U12220233, U12220234, U12220235, U12220236, U12220237, V01080056, V01080057, V01110221, V01110222, V01110223, V01110224, V02200066, V02200067, V02200068, V02200069, V02200070, V02200071, V03190037, V03190038, V03290055, V03290056, V04090143, V04090144, V04090145, V04090146, V04090147, V04090148, V04090149, V04090150, V04090151, V04090152, V05020831
Model numbers872

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.

Reason for recall

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

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0694-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.