Z-1311-06

TEKLENS II (TEKIA label) and Polylens A60 (Polytech label) Model 614, intraocular lens (IOL)

Name: Z-1311-06 TEKLENS II (TEKIA label) and Polylens A60 (Polytech label) Model 614, intraocular lens (IOL)
Creator: Tekia Inc
Published: 2004-07-02
License: https://open.fda.gov/license/

Tekia Inc / initiated 2004-07-02 / Terminated / root cause: labeling and UDI

FDA source

Tekia Inc began a recall of TEKLENS II (TEKIA label) and Polylens A60 (Polytech label) Model 614, intraocular lens (IOL) on 2004-07-02. The reason FDA records is "Intraocular lenses (IOLs) with power of 17.0 D and 22.5 D are mislabeled with each other's labels". 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-1311-06
Status: Terminated
Initiated: 2004-07-02
Posted: 2006-08-02
Terminated: 2012-02-10
Recalling firm: Tekia Inc
Product: TEKLENS II (TEKIA label) and Polylens A60 (Polytech label) Model 614, intraocular lens (IOL)
Product code: HQL Intraocular Lens
Reason for recall: Intraocular lenses (IOLs) with power of 17.0 D and 22.5 D are mislabeled with each other's labels.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: On 7/2/04, TEKIA informs first customer to stop shipment of 22.5 D IOLs from batch E0310 due to suspicion of mislabeling. On 7/8/2004 TEKIA informs first customer to stop shipping IOLs belonging to two shop orders (22.5 D E03100099-120- twenty-two (22) units, 17.0 D E100064-89- twenty-six (26) units), and requests them to retrieve products with those serial numbers from their customers. TEKIA informs second customer of suspicion of mislabeling, requests stop shipment and retrieval from their customers of the IOLs belonging to two shop orders: twelve (12) IOLs 22.5 D E03100146-153 -- eight (8) units, 22.5 D E03100218-221 --four (4) units. Return Goods Authorizations are issued.
Quantity in commerce: 60 units/IOLs total
Distribution: Germany.
Product codes and lots: 1) Products labeled with TEKIA as manufacturer: IOLs with power of 17.0 D (4 units): 616170E031002180207, 616170E031002190207, 616170E031002200207, 616170E031002210207; IOLs with power of 22.5 D (8 units): 616225E031001460207, 616225E031001470207, 616225E031001480207, 616225E031001490207, 616225E031001500207, 616225E031001510207; 616225E031001520207, 616225E031001530207. 2) Products labeled with Polytech as manufacturer: IOLs with power of 17.0 D (26 units): 613170E031000640207, 613170E031000650207, 613170E031000660207, 613170E031000670207, 613170E031000680207, 613170E031000690207, 613170E031000700207, 613170E031000710207,613170E031000720207, 613170E031000730207, 613170E031000740207, 613170E031000750207, 613170E031000760207, 613170E031000770207, 613170E031000780207, 613170E031000790207, 613170E031000800207, 613170E031000810207, 613170E031000820207, 613170E031000830207, 613170E031000840207, 613170E031000851207, 613170E031000860207, 613170E031000870207, 613170E031000880207, 613170E031000890207; IOLs with power of 22.5 D (22 units): 613225E031000990207, 613225E031001000207, 613225E031001010207, 613225E031001020207, 613225E031001030207, 613225E031001040207, 613225E031001050207, 613225E031001060207, 613225E031001070207, 613225E031001080207, 613225E031001090207, 613225E031001100207, 613225E031001110207, 613225E031001120207, 613225E031001130207, 613225E031001140207, 613225E031001150207, 613225E031001160207, 613225E031001170207, 613225E031001180207, 613225E031001190207, 613225E031001200207.

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)