Cl II ORA System with VerifEye

Company:Alcon Research, Ltd..
Date of Enforcement Report 8/30/2017
ClasslI:

PRODUCT

ORA System with VerifEye, Catalog Number 8065998300 For use during intraocular lens surgery
Recall Number Z-3050-2017

REASON
Some ORA Carts have the potential to return an incorrect IOL power measurement during cataract surgery. This issue appears to have been caused by a software coding error that results in the lens coefficients for an IOL model being downloaded from the Alcon server in an incorrect order..

RECALLING FIRM/MANUFACTURER
Alcon Research, Ltd., Fort Worth TX on 6/30/2017. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
367 units

DISTRIBUTION
Nationwide and Internationally

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Software Verification

Do you have gaps with IEC 62304 compliance or with FDA expectations for software verification?  We can help you quickly remediate gaps with unit verification including unit testing, code review, and static analysis, as well as integration and system verification testing.  Call us at 781-721-2921 or email office@softwarecpr.com to start a conversation.  We can provide estimates of cost and support your development tools.

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.