Class II — Haag-Streit USA Inc
| Recalling firm | HAAG-STREIT HOLDING |
|---|---|
| Registered facility | View this company's 5 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | There is a possibility for data to be stored under the wrong patient on the DICOM Server following a non-standard workflow. |
| Product | EyeSuite i.8.2.1.0 Software for ophthalmic use including selection of Intra Ocular Lenses (IOLs). |
| Quantity | 163 units |
| Distribution | US Nationwide distribution. |
| Initiated | 2017-01-05 |
| Classified | 2017-03-20 |
| Terminated | 2019-03-22 |
| Recall number | Z-1500-2017 |
| 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 — Haag-Streit USA Inc (Z-1500-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/76405/
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