FDA Device recall Z-1560-2021
Eyesuite 9.3.1 software, LENSTAR, MODEL LS900: ac-powered slit-lamp biomicroscope
- FDA Device
- Class II
- ongoing
- Published 2021-05-19
On 2021-05-19 the FDA classified a Class II recall of Eyesuite 9.3.1 software, LENSTAR, MODEL LS900: ac-powered slit-lamp biomicroscope by Haag Streit Usa, citing 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).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1560-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-04-15 |
| Published | 2021-05-19 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Haag Streit Usa |
| Distribution | US |
Product
Eyesuite 9.3.1 software, LENSTAR, MODEL LS900: ac-powered slit-lamp biomicroscope.
Reason
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).
Identifiers
| code_info | Software version 9.3.1 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1560-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.