Z-0237-2016Class II

TEKIA Single Piece Hydrophilic Acrylic Intraocular Lenses, Model 811

Name: Z-0237-2016 TEKIA Single Piece Hydrophilic Acrylic Intraocular Lenses, Model 811
Creator: Tekia, Inc.
Published: 2015-09-29
License: https://open.fda.gov/license/

Tekia Inc / initiated 2015-09-29 / Terminated / root cause: labeling and UDI

FDA source

Tekia, Inc. began a recall of TEKIA Single Piece Hydrophilic Acrylic Intraocular Lenses, Model 811 on 2015-09-29. FDA classified it as Class II and gives the reason as "Tekia is recalling the Single Piece Hydrophillic Acrylic Intraocular Lenses (IOLs) because they may be labeled with the incorrect diopter power". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0237-2016
Classification: Class II
Status: Terminated
Initiated: 2015-09-29
Posted: 2015-11-06
Terminated: 2015-12-03
Recalling firm: Tekia Inc
Product: TEKIA Single Piece Hydrophilic Acrylic Intraocular Lenses, Model 811
Product code: HQL Intraocular Lens
Reason for recall: Tekia is recalling the Single Piece Hydrophillic Acrylic Intraocular Lenses (IOLs) because they may be labeled with the incorrect diopter power.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: Tekia sent an Field Safety Notice dated September 29, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. Customers were advised that Tekia is recalling a limited a number of Single Piece Hydrophilic Acrylic IOLs. If the customer has any questions, the customer is instructed to contact a TEKIA Customer Service or QA Representative at (949) 699-1300. Customers with product complaints or adverse events regarding the use of Single Piece Hydrophilic Acrylic IOLs are instructed to inform TEKIA by phone, email, or fax.
Quantity in commerce: 50 units
Distribution: Internationally to Vietnam.
Product codes and lots: SN: U07310001 thru U07310040 , 07310050 thru U07310059

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0237-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0237-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-18	2015-11-06

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)