Eyesuite 9 — Class II medical device recall Z-1560-2021
Ongoing recall by Haag-Streit USA Inc, reported 2021-05-19, distributed nationwide. Examination data and patient name may be mixed up when printing or generating a pdf with the interface at Paci
| Recall number | Z-1560-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Haag-Streit USA Inc, Mason, OH, United States |
| Recall initiated | 2021-04-15 |
| Classified | 2021-05-11 |
| Reported by FDA | 2021-05-19 |
| Distributed | Nationwide (US) |
| Model numbers | LS900 |
Product
Eyesuite 9.3.1 software, LENSTAR, MODEL LS900: ac-powered slit-lamp biomicroscope.
Reason for recall
Examination data and patient name may be mixed up when printing or generating a pdf with the interface at Pacific Coast and Laser Institute (PCLI).
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-1560-2021. 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.