Recall - Biomicroscope software inadvertently mixes up patient data

Company: Haag-Streit USA Inc.
Date of Enforcement Report: 5/19/2021
Class II

PRODUCT

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

Recall Number: Z-1560-2021

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).

RECALLING FIRM/MANUFACTURER

Haag-Streit USA Inc on 4/15/2021. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

DISTRIBUTION

U.S. Nationwide

Recall – Biomicroscope software inadvertently mixes up patient data