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

FDA device recall Z-1311-06 · posted 2006-08-02 · Terminated

Recall details

Recalling firm

Tekia Inc

Reason for recall

Intraocular lenses (IOLs) with power of 17.0 D and 22.5 D are mislabeled with each other's labels.

Action taken

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.

Root cause

Other

Status

Terminated

Product code

HQL

Quantity affected

60 units/IOLs total

Distribution

Germany.

Date initiated

2004-07-02

Date posted

2006-08-02

Date terminated

2012-02-10

Location

Irvine, CA