Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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

FDA Recall Z-1311-06 · Posted 2006-08-02

Recalling FirmTekia Inc
Recall StatusTerminated
Product CodeHQL
Date Initiated2004-07-02
Date Terminated2012-02-10
Product Quantity60 units/IOLs total

Reason for Recall

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

Firm 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.

Root Cause

Other

Distribution Pattern

Germany.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑