Haag-Streit Eyesuite 9.3.1 Software Recall: Patient Data Mix-Up Risk
Haag-Streit recalls Eyesuite 9.3.1 software for LENSTAR LS900 slit-lamp biomicroscopes due to potential mixing of patient data and names when printing PDFs at Pacific Coast and Laser Institute. Affected units may need software updates.
Lower-risk 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).
Contact the company
What happened, in plain English
Haag-Streit is recalling Eyesuite 9.3.1 software for their LENSTAR LS900 slit-lamp biomicroscopes. This software version can mix up patient data and names when generating PDFs at specific clinics, which could lead to incorrect medical records. Read more at govinfonow.com/recall/62784-haag-streit-eyesuite-9-3-1-software-recall-patient-data.
Source Summary by GovInfoNow · govinfonow.com/recall/62784-haag-streit-eyesuite-9-3-1-software-recall-patient-data · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1560-2021
Cite this page
“Haag-Streit Eyesuite 9.3.1 Software Recall: Patient Data Mix-Up Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62784-haag-streit-eyesuite-9-3-1-software-recall-patient-data. Based on FDA recall #Z-1560-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1560-2021%22&limit=1).
Why it’s dangerous
The software version 9.3.1 can mix up patient data and names when printing or generating PDFs at Pacific Coast and Laser Institute (PCLI). This error could lead to incorrect medical records being created for patients during eye exams.
Who’s affected
Ophthalmologists and their clinics using the Eyesuite 9.3.1 software version with the LENSTAR LS900 model. Patients at Pacific Coast and Laser Institute (PCLI) clinics are most at risk of incorrect medical records.
How to tell if you have this one
Check if your LENSTAR LS900 slit-lamp biomicroscope uses Eyesuite 9.3.1 software. The issue occurs specifically at Pacific Coast and Laser Institute (PCLI) clinics.
- Brand
Haag-Streit- Category
Medical device
What to do — step by step
Update Software
Contact Haag-Streit to update to a newer software version that fixes the data mix-up issue.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US Nationwide distribution in the state of WA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 34 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is this software issue dangerous?
The recall indicates a risk of incorrect patient data and names in PDFs at PCLI clinics, but it does not involve physical harm or serious injury.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1560-2021 (April 15, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1560-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.