Recall Z-1311-06 ยท HQL Intraocular Lens
Tekia Inc
TEKLENS II (TEKIA label) and Polylens A60 (Polytech label) Model 614, intraocular lens (IOL)
| Date | Aug 2, 2006 (initiated Jul 2, 2004) |
| Status | Terminated |
| Reason | Intraocular lenses (IOLs) with power of 17.0 D and 22.5 D are mislabeled with each other's labels. |
| 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) |
| Quantity | 60 units/IOLs total |
| Distribution | Germany. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.