The Recall Desk
HighFDA (Devices)·Z-3049-2017·Announced 2017-08-30

Alcon ORA System Recall for Incorrect IOL Power Measurements

Alcon is recalling 429 ORA Systems with VerifEye+ Carts due to a software error that may cause incorrect intraocular lens power measurements during cataract surgery.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device used during surgery where a software error could lead to incorrect measurements, posing a risk of harm to patients, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Alcon Research, Ltd. is recalling 429 units of the ORA System with VerifEye+ Cart (Catalog Number 8065998307). The recall is due to a software coding error that may cause the system to return an incorrect intraocular lens (IOL) power measurement during cataract surgery. The error occurs when lens coefficients for an IOL model are downloaded from the Alcon server in an incorrect order.

The affected units were distributed worldwide, including in the United States and numerous international markets such as Argentina, Australia, Belgium, Brazil, Canada, China, Colombia, France, India, Japan, Mexico, the Netherlands, Panama, Portugal, Romania, Spain, Thailand, the UAE, and the United Kingdom. The recall covers specific serial numbers ranging from C5013 to C5555.

Healthcare providers and patients should verify if their equipment is affected by checking the serial number against the provided list. Alcon is the recalling firm responsible for addressing this issue.

The recalled product

Product
ORA System with VerifEye+ Cart, Catalog Number 8065998307 For use during intraocular lens surgery
Manufacturer
Alcon Research, Ltd.
Category
Medical Device — Ophthalmic Surgical Equipment
Hazard
Affected units
429

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Serial numbers: C5013
  • C5014
  • C5015
  • C5016
  • C5017
  • C5018
  • C5019
  • C5020
  • C5021
  • C5023
  • C5024
  • C5025
  • C5026
  • C5027
  • C5028
  • C5029
  • C5030
  • C5031
  • C5032
  • C5033

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Alcon Research, Ltd. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Alcon Research, Ltd.

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Same hazard · software error

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