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Recall Observatory FDA recall evidence

Device product

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

Z-1560-2021

April 15, 2021

Class II

Product summary

Firm
Haag-Streit USA Inc
Event
Event 87766
Status
Ongoing
Classification
Class II
Quantity
Unavailable
Official record key
device-enforcement:Z-1560-2021

Official wording

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).

Code information: Software version 9.3.1

Distribution pattern: US Nationwide distribution in the state of WA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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).