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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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.
- 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.
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