PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: May 19, 2021 Initiated: April 15, 2021 #Z-1560-2021

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).

Details

Recalling Firm
Haag-Streit USA Inc
Distribution
US Nationwide distribution in the state of WA.
Location
Mason, OH

Frequently Asked Questions

What product was recalled?
Eyesuite 9.3.1 software, LENSTAR, MODEL LS900: ac-powered slit-lamp biomicroscope.. Recalled by Haag-Streit USA Inc.
Why was this product 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).
Which agency issued this recall?
This recall was issued by the FDA Devices on May 19, 2021. Severity: Moderate. Recall number: Z-1560-2021.