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
NA
DISTRIBUTION
U.S. Nationwide