Mar

2017

Cl II EyeSuite i.8.2.1.0 Software

Company: Haag-Streit USA Inc
Date of Enforcement Report 3/29/2017
Class lI:

PRODUCT

EyeSuite i.8.2.1.0 Software for ophthalmic use including selection of Intra Ocular Lenses (IOLs).
Recall Number Z-1500-2017

REASON
There is a possibility for data to be stored under the wrong patient on the DICOM Server following a non-standard workflow.

RECALLING FIRM/MANUFACTURER
Haag-Streit USA Inc., Mason OH on 1/5/2017. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
163

DISTRIBUTION
Nationwide

___________________________________

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Cl II EyeSuite i.8.2.1.0 Software

Amy Sellers

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