Z-1560-2021Class II

Eyesuite 9.3.1 software, LENSTAR, MODEL LS900: ac-powered slit-lamp biomicroscope

Name: Z-1560-2021 Eyesuite 9.3.1 software, LENSTAR, MODEL LS900: ac-powered slit-lamp biomicroscope
Creator: Haag-Streit USA Inc
Published: 2021-04-15
License: https://open.fda.gov/license/

Haag-Streit USA Inc / initiated 2021-04-15 / Open, Classified / root cause: software

FDA source

Haag-Streit USA Inc began a recall of Eyesuite 9.3.1 software, LENSTAR, MODEL LS900: ac-powered slit-lamp biomicroscope on 2021-04-15. FDA classified it as Class II and gives the reason as "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)". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1560-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-04-15
Posted: 2021-05-11
Recalling firm: Haag-Streit USA Inc
Product: Eyesuite 9.3.1 software, LENSTAR, MODEL LS900: ac-powered slit-lamp biomicroscope.
Product code: HJO Biomicroscope, Slit-Lamp, Ac-Powered
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).
Root cause tag: software
FDA root cause: Software design
Action: On 04/06/2021, Haag-Streit issued an Urgent Medical Device Correction notice to their customer via letter notifying them Eyesuite 9.3.1 software may mix up examination data and patient name when printing or generating a PDF.
Distribution: US Nationwide distribution in the state of WA.
Product codes and lots: Software version 9.3.1

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1560-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1560-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-05-19	2021-05-11

Product code HJO

K082891Class IILenstar, Model Ls900Haag-Streit AG / cleared 2009-10-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)