Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Open, Classified

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

FDA Recall Z-1560-2021 · Posted None

Recalling FirmHaag-Streit USA Inc
Recall StatusOpen, Classified
Product CodeHJO
Date Initiated2021-04-15

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).

Firm 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.

Root Cause

Software design

Distribution Pattern

US Nationwide distribution in the state of WA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K082891LENSTAR, MODEL LS900Haag-Streit AG · 2009-10-20

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑