FDA Device recall Z-0237-2016
TEKIA Single Piece Hydrophilic Acrylic Intraocular Lenses, Model 811
- FDA Device
- Class II
- terminated
- Published 2015-11-18
On 2015-11-18 the FDA classified a Class II recall of TEKIA Single Piece Hydrophilic Acrylic Intraocular Lenses, Model 811 by Tekia, citing tekia is recalling the Single Piece Hydrophillic Acrylic Intraocular Lenses (IOLs) because they may be labeled with the incorrect diopter power.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0237-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-09-29 |
| Published | 2015-11-18 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Tekia |
| Distribution | n/a |
Product
TEKIA Single Piece Hydrophilic Acrylic Intraocular Lenses, Model 811
Reason
Tekia is recalling the Single Piece Hydrophillic Acrylic Intraocular Lenses (IOLs) because they may be labeled with the incorrect diopter power.
Identifiers
| code_info | SN: U07310001 thru U07310040 , 07310050 thru U07310059 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0237-2016%22
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