FDA-Device2017-08-30Class II
ORA System with VerifEye, Catalog Number 8065998300 For use during intraocular lens surgery
Alcon Research, Ltd.
Hazard
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.
Sold states
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
Affected count
367 units
Manufactured in
6201 South Fwy, Fort Worth, TX, United States
Products
ORA System with VerifEye, Catalog Number 8065998300 For use during intraocular lens surgery
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3050-2017Don't want to check this manually?
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