Recall Z-1560-2021 ยท HJO Biomicroscope, Slit-Lamp, Ac-Powered
Haag-Streit USA Inc
Eyesuite 9.3.1 software, LENSTAR, MODEL LS900: ac-powered slit-lamp biomicroscope.
| Date | Apr 15, 2021 |
| Status | Open, Classified |
| 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). |
| Root cause | Software design |
| Action | On 04/06/2021, Haag-Streit issued an Urgent Medical Device Correction notice to their customer via letter notifying them Eyesuite 9.3.1 software may mix up examination data and patient name when printing or generating a PDF. |
| Distribution | US Nationwide distribution in the state of WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082891 | LENSTAR, MODEL LS900 Haag-Streit AG, Oct 20, 2009 |