FDA recall Z-1560-2021

Haag-Streit USA Inc · Class II · device

Product

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).

Distribution

US Nationwide distribution in the state of WA.

Key facts

Status
Ongoing
Initiation date
2021-04-15
Report date
2021-05-19
Voluntary/Mandated
Voluntary: Firm initiated
Location
Mason, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1560-2021