Reported Aug 30, 2017 · Terminated
ORA System with VerifEye+ Cart, Catalog Number 8065998307 For use during intraocular lens surgery
Alcon Research, Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Alcon Research, Ltd. · 6201 South Fwy · Fort Worth, TX · 76134-2099
Is this the product you have?
- ORA System with VerifEye+ Cart, Catalog Number 8065998307 For use during intraocular lens surgery
- Lot codes and dates
- Serial numbers
429 of 429 codes
C5013C5014C5015C5016C5017C5018C5019C5020C5021C5023C5024C5025C5026C5027C5028C5029C5030C5031C5032C5033C5034C5035C5036C5038C5039C5040C5041C5042C5043C5044C5045C5046C5047C5048C5049C5050C5051C5053C5054C5055C5059C5060C5061C5062C5064C5065C5066C5069C5071C5075C5076C5077C5078C5079C5080C5081C5082C5083C5090C5093
- Serial numbers
- Amount recalled
- 429 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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