FDA recall Z-3050-2017

Product

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

Reason for recall

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.

Distribution

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

Key facts

Status

Terminated

Initiation date

2017-06-30

Report date

2017-08-30

Termination date

2019-08-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

Fort Worth, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3050-2017