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Alcon Research, Ltd. recalls ORA System with VerifEye+ Cart, Catalog Number 8065998307 For use during intraocular lens surgery
Recalled August 30, 2017 · FDA recall Z-3049-2017 · Alcon Research
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. · FDA Class II
Units
429 units
Sold at
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
Description
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.
Product
ORA System with VerifEye+ Cart, Catalog Number 8065998307 For use during intraocular lens surgery
Manufacturer(s)
Alcon Research, Ltd.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →