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Terminated

ORA System with VerifEye+ Cart, Catalog Number 8065998307 For use during intraocular lens surgery

FDA Recall Z-3049-2017 · Posted None

Recalling FirmAlcon Research, Ltd.
Recall StatusTerminated
Product CodeNCF
Date Initiated2017-06-30
Date Terminated2019-08-27
Product Quantity429 units

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.

Firm Action

The Market Action was initiated with Initial telephone contact to all affected customers starting June 30, 2017. These customers were informed of the issue, and advised not to use their ORA Carts for calculations with the lens model affected on their specific system. A confirmatory letter (Attachment 4) was also sent via overnight mail to these customers July 12, 2017. As of July 12, 2017, Alcon has identified 8 ORA Carts that are affected by the software coding error. Alcon has reset the IOL databases on all 8 of the identified affected ORA Carts.

Root Cause

Software design

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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