Recall Z-3050-2017— Alcon Research, Ltd.
Class II · Terminated
Class II FDA medical device recall by Alcon Research, Ltd., initiated 2017-06-30, terminated 2019-08-27. FDA's recall record names no specific 510(k) clearance for this event. Product: ORA System with VerifEye, Catalog Number 8065998300 For use during intraocular lens surgery. Reason: 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..
- Recalling firm
- Alcon Research, Ltd.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-06-30
- Terminated
- 2019-08-27
- Firm location
- Fort Worth, TX, United States
Product description
ORA System with VerifEye, Catalog Number 8065998300 For use during intraocular lens surgery
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.