# FDA recall Z-3049-2017

> **Alcon Research, Ltd.** · Class II · device recall initiated 2017-06-30.

## Product

ORA System with VerifEye+ Cart, Catalog Number 8065998307  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

- **Recall number:** Z-3049-2017
- **Recalling firm:** Alcon Research, Ltd.
- **Classification:** Class II
- **Product type:** device
- **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

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3049-2017

## Citation

> AI Analytics. FDA recall Z-3049-2017. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-3049-2017. Source: US FDA. Licensed CC0.

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