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U.S. Department of Health and Human Services

Class 2 Device Recall Eyesuite 9.3.1 software.

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  Class 2 Device Recall Eyesuite 9.3.1 software. see related information
Date Initiated by Firm April 15, 2021
Create Date May 11, 2021
Recall Status1 Open3, Classified
Recall Number Z-1560-2021
Recall Event ID 87766
510(K)Number K082891  
Product Classification Biomicroscope, slit-lamp, ac-powered - Product Code HJO
Product Eyesuite 9.3.1 software, LENSTAR, MODEL LS900: ac-powered slit-lamp biomicroscope.
Code Information Software version 9.3.1
Recalling Firm/
Manufacturer		 Haag-Streit USA Inc
3535 Kings Mills Rd
Mason OH 45040-2303
For Additional Information Contact Michael J. Dietz
513-398-3937
Manufacturer 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).
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = HJO and Original Applicant = HAAG-STREIT AG
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