The Recall Desk
HighFDA (Devices)·Z-3050-2017·Announced 2017-08-30

Alcon ORA System Recall for Incorrect IOL Power Measurements

Alcon is recalling 367 ORA Systems with VerifEye because a software error 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 is classified as FDA Class II, and the hazard involves a risk of harm (incorrect surgical measurements) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Alcon Research, Ltd. is recalling 367 units of the ORA System with VerifEye, Catalog Number 8065998300. This medical device is used during intraocular lens (IOL) surgery. The recall covers units distributed worldwide, including the United States and numerous international markets.

The recall is due to a software coding error that may cause the system to return an incorrect IOL power measurement. This issue occurs when lens coefficients for an IOL model are downloaded from the Alcon server in an incorrect order. The source text does not report any specific injuries or illnesses associated with this defect.

Healthcare providers and patients should check their device serial numbers against the list provided in the official recall notice. If a device is affected, it should be removed from service and returned to Alcon for repair or replacement.

The recalled product

Product
ORA System with VerifEye, Catalog Number 8065998300 For use during intraocular lens surgery
Manufacturer
Alcon Research, Ltd.
Category
Medical Device — Ophthalmic Surgical Equipment
Hazard
Affected units
367

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: C0002
  • C2006
  • C2020
  • C2026
  • C2054
  • C3009R
  • C3010R
  • C3024
  • C3036
  • C3066
  • C3067
  • C3085R
  • C3090
  • C3093
  • C3108
  • C3136
  • C3153
  • C4001
  • C4003
  • C4005

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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