Cl II ORA System with VerifEye+ Cart

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

PRODUCT

ORA System with VerifEye+ Cart, Catalog Number 8065998307 For use during intraocular lens surgery.
Recall Number Z-3049-2017

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
429 units

DISTRIBUTION
Nationwide and Internationally

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Upcoming Training

62304, FDA, and Emerging Standards for Medical Device and HealthIT
Instructors:  Brian Pate, John F. Murray, Jr
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Dates:  February 4-6, 2020
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Location: Boston, MA, USA
Dates:  June 2-4, 2020
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Corporate Office

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