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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