FDA Enforcement
Class II
Ongoing
Eyesuite 9.3.1 software, LENSTAR, MODEL LS900: ac-powered slit-lamp biomicroscope.
Recall: Z-1560-2021
·
Reported May 19, 2021
Enforcement
- Recall Number
- Z-1560-2021
- Event ID
- 87766
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Haag-Streit USA Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- May 19, 2021
- Initiation Date
- April 15, 2021
- Classification Date
- May 11, 2021
- Address
- 3535 Kings Mills Rd, Mason, OH, 45040-2303, United States
Description
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).
Code Info
Software version 9.3.1
Distribution
US Nationwide distribution in the state of WA.