ORA System with VerifEye, Catalog Number 8065998300 For use during intraocular lens surgery
Reported: August 30, 2017 Initiated: June 30, 2017 #Z-3050-2017
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.
Details
- Recalling Firm
- Alcon Research, Ltd.
- Units Affected
- 367 units
- Distribution
- Worldwide distribution. US Nationwide and Argentina, Australia, Belgium, Brazil, Canada, China, Colombia, France, India, Japan, Mexico, Netherlands, Panama, Portugal, Romania, Spain, Thailand, UAE, and United Kingdom
- Location
- Fort Worth, TX
Frequently Asked Questions
What product was recalled? ▼
ORA System with VerifEye, Catalog Number 8065998300 For use during intraocular lens surgery. Recalled by Alcon Research, Ltd.. Units affected: 367 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 30, 2017. Severity: Moderate. Recall number: Z-3050-2017.
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