Alcon Research, Ltd. recalls ORA System with VerifEye, Catalog Number 8065998300 For use during intraocular lens surgery

Recall date

June 30, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-3050-2017

FDA classification

Class II

Brand / firm

Alcon Research, Ltd.

Sold / distributed

Worldwide distribution. US Nationwide and Argentina, Australia, Belgium, Brazil, Canada, China, Colombia, France, India, Japan, Mexico, Netherlands, Panama, Portugal, Romania, Spain, Thailand, UAE, and United Kingdom

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

ORA System with VerifEye, Catalog Number 8065998300 For use during intraocular lens surgery