Company:Alcon Research, Ltd..
Date of Enforcement Report 8/30/2017
ORA System with VerifEye+ Cart, Catalog Number 8065998307 For use during intraocular lens surgery.
Recall Number Z-3049-2017
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..
Alcon Research, Ltd., Fort Worth TX on 6/30/2017. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
Nationwide and Internationally