|
Class 2 Device Recall TEKLENS II and Polylens A60 |
|
Date Initiated by Firm |
July 02, 2004 |
Date Posted |
August 02, 2006 |
Recall Status1 |
Terminated 3 on February 10, 2012 |
Recall Number |
Z-1311-06 |
Recall Event ID |
35817 |
Product Classification |
intraocular lens - Product Code HQL
|
Product |
TEKLENS II (TEKIA label) and Polylens A60 (Polytech label) Model 614, intraocular lens (IOL) |
Code Information |
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. |
Recalling Firm/ Manufacturer |
Tekia Inc 17 Hammond Suite 414 Irvine CA 92618
|
For Additional Information Contact |
Pascale David 949-699-1300
|
Manufacturer Reason for Recall |
Intraocular lenses (IOLs) with power of 17.0 D and 22.5 D are mislabeled with each other's labels.
|
FDA Determined Cause 2 |
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. |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
|
|
|