Aug

2017

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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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 ORA System with VerifEye

Amy Sellers

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