FDA Device recall Z-0694-2020

TEKIA Model 872 Single Piece Hydrophilic Acrylic Intraocular Lenses, Diopter 15.0, Sterile

FDA Device
Class II
terminated
Published 2019-12-25

On 2019-12-25 the FDA classified a Class II recall of TEKIA Model 872 Single Piece Hydrophilic Acrylic Intraocular Lenses, Diopter 15.0, Sterile by Tekia, citing A limited number of lenses may be mislabeled with the incorrect diopter power.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0694-2020
Classification	Class II
Status	terminated
Initiated	2018-11-09
Published	2019-12-25
Last updated	2026-09-13 11:55 UTC
Company	Tekia
Distribution	n/a

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

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

Identifiers

code_info	36 recalled serial numbers from Lot 522-003: U12220229, U12220230, U12220231, U12220232, U12220233, U12220234, U12… 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.

code_info

36 recalled serial numbers from Lot 522-003: U12220229, U12220230, U12220231, U12220232, U12220233, U12220234, U12…

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.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0694-2020%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.