Devices

Device Recall TEKLENS II and Polylens A60

Model / Serial
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 Classification
Ophthalmic Devices
Device Class
3
Implanted device?
Yes
Distribution
Germany.
Product Description
TEKLENS II (TEKIA label) and Polylens A60 (Polytech label) Model 614, intraocular lens (IOL)
Manufacturer
Tekia Inc
1 Event
- Recall of Device Recall TEKLENS II and Polylens A60

Manufacturer

Tekia Inc

Manufacturer Address
Tekia Inc, 17 Hammond, Suite 414, Irvine CA 92618
Source
USFDA

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