Tekia Inc
Irvine, CA, US
TEKIA, INC. appears in FDA device records in Irvine, CA. FDA records list no 510(k) clearances, no PMA records and one registered establishment. As of , FDA records show 3 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2031474 | 3002023310 | TEKIA, INC. | 17 Hammond, Irvine, CA 92618 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0694-2020 | TEKIA Model 872 Single Piece Hydrophilic Acrylic Intraocular Lenses, Diopter 15.0, Sterile. The firm name on the label is TEKIA, INC., Irvine, CA. | A limited number of lenses may be mislabeled with the incorrect diopter power. | Class II | Terminated | |
| Z-0237-2016 | TEKIA Single Piece Hydrophilic Acrylic Intraocular Lenses, Model 811 | Tekia is recalling the Single Piece Hydrophillic Acrylic Intraocular Lenses (IOLs) because they may be labeled with the incorrect diopter power. | Class II | Terminated | |
| Z-1311-06 | TEKLENS II (TEKIA label) and Polylens A60 (Polytech label) Model 614, intraocular lens (IOL) | Intraocular lenses (IOLs) with power of 17.0 D and 22.5 D are mislabeled with each other's labels. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain