Haag-Streit USA Inc Eyesuite 9.3.1 software, LENSTAR, MODEL LS900: ac-powered slit-lamp biomicroscope. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Eyesuite 9.3.1 software, LENSTAR, MODEL LS900: ac-powered slit-lamp biomicroscope.
Brand
Haag-Streit USA Inc
Lot Codes / Batch Numbers
Software version 9.3.1
Products Sold
Software version 9.3.1
Haag-Streit USA Inc is recalling Eyesuite 9.3.1 software, LENSTAR, MODEL LS900: ac-powered slit-lamp biomicroscope. due to 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).. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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).
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026