Recall Z-1560-2021— Haag-Streit USA Inc

Name: FDA recall Z-1560-2021
Creator: U.S. Food and Drug Administration
Published: 2021-04-15

Class II · Ongoing

Class II FDA medical device recall by Haag-Streit USA Inc, initiated 2021-04-15. It names one FDA 510(k) clearance: K082891. Product: Eyesuite 9.3.1 software, LENSTAR, MODEL LS900: ac-powered slit-lamp biomicroscope.. 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: Haag-Streit USA Inc
Classification: Class II
Status: Ongoing
Initiated: 2021-04-15
Firm location: Mason, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K082891 — LENSTAR, MODEL LS900Haag-Streit AG·cleared 2009-10-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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).

Data sourced from openFDA. This site is unofficial and independent of the FDA.