Class II — Tekia, Inc.
| Recalling firm | TEKIA, INC |
|---|---|
| Registered facility | TEKIA, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | A limited number of lenses may be mislabeled with the incorrect diopter power. |
| Product | TEKIA Model 872 Single Piece Hydrophilic Acrylic Intraocular Lenses, Diopter 15.0, Sterile. The firm name on the label is TEKIA, INC., Irvine, CA. |
| Quantity | 81 IOLs were distributed but only 36 within expiry were recalled |
| Distribution | There was no U.S. distribution. Foreign distribution was made to Iran, Korea, Luxembourg, and Vietnam. |
| Initiated | 2018-11-09 |
| Classified | 2019-12-17 |
| Terminated | 2020-09-16 |
| Recall number | Z-0694-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Tekia, Inc. (Z-0694-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/83903/
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