TEKIA Single Piece Hydrophilic Acrylic Intraocular Lenses — Class II medical device recall Z-0237-2016
Terminated recall by Tekia, Inc., reported 2015-11-18. Tekia is recalling the Single Piece Hydrophillic Acrylic Intraocular Lenses (IOLs) because they may be labeled
| Recall number | Z-0237-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Tekia, Inc., Irvine, CA, United States |
| Recall initiated | 2015-09-29 |
| Classified | 2015-11-06 |
| Reported by FDA | 2015-11-18 |
| Terminated | 2015-12-03 |
| Countries outside the US | VN |
| Quantity | 50 units |
| Reason classes | labeling |
| Model numbers | 811 |
Product
TEKIA Single Piece Hydrophilic Acrylic Intraocular Lenses, Model 811
Reason for recall
Tekia is recalling the Single Piece Hydrophillic Acrylic Intraocular Lenses (IOLs) because they may be labeled with the incorrect diopter power.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0237-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.