Z-0694-2020Class II

TEKIA Model 872 Single Piece Hydrophilic Acrylic Intraocular Lenses, Diopter 15.0, Sterile. The firm name on...

Name: Z-0694-2020 TEKIA Model 872 Single Piece Hydrophilic Acrylic Intraocular Lenses, Diopter 15.0, Sterile. The firm name on...
Creator: Tekia, Inc.
Published: 2018-11-09
License: https://open.fda.gov/license/

Tekia Inc / initiated 2018-11-09 / Terminated / root cause: manufacturing process

FDA source

Tekia, Inc. began a recall of TEKIA Model 872 Single Piece Hydrophilic Acrylic Intraocular Lenses, Diopter 15.0, Sterile. The firm name on the label is TEKIA, INC., Irvine, CA on 2018-11-09. FDA classified it as Class II and gives the reason as "A limited number of lenses may be mislabeled with the incorrect diopter power". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0694-2020
Classification: Class II
Status: Terminated
Initiated: 2018-11-09
Posted: 2019-12-17
Terminated: 2020-09-16
Recalling firm: Tekia Inc
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.
Product code: HQL Intraocular Lens
Reason for recall: A limited number of lenses may be mislabeled with the incorrect diopter power.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The recalling firm issued letters dated 11/9/2018 notifying the consignee to take the following actions: 1) to stop using the device and remove the product from inventory, 2) inform TEKIA by email ([email protected], [email protected]) within 3 working days of all the retrieved and already implanted Single Piece Hydrophilic Acrylic IOLs listed in the letter, including serial numbers, and 3) destroy the product once every affected IOL is removed out from your inventory and forward evidence of destruction with corresponding serial numbers by email ([email protected], [email protected]). If you have any questions, please contact a TEKIA Customer Service or QA Representative at (949)-699-1300.
Quantity in commerce: 81 IOLs were distributed but only 36 within expiry were recalled
Distribution: There was no U.S. distribution. Foreign distribution was made to Iran, Korea, Luxembourg, and Vietnam.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0694-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0694-2020	Class II	Terminated	Voluntary: Firm initiated	2019-12-25	2019-12-17

Product code HQL

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)