Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

ORA System with VerifEye+ Cart Recalled by Alcon Research, Ltd. Due to Some ORA Carts have the potential to return...

Date: June 30, 2017
Company: Alcon Research, Ltd.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Alcon Research, Ltd. directly.

Affected Products

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

Quantity: 429 units

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Alcon Research, Ltd.

Alcon Research, Ltd. has 26 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report