Medical device recalls Moderate risk

Haag-Streit USA Inc recalls Eyesuite 9.3.1 software, LENSTAR, MODEL LS900: ac-powered slit-lamp biomicroscope.

Recall date
April 15, 2021
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1560-2021
FDA classification
Class II
Brand / firm
Haag-Streit USA Inc
Sold / distributed
US Nationwide distribution in the state of WA.

Why it was recalled

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).

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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