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.
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 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.
- 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.
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