Reported Aug 30, 2017 · Terminated
ORA System with VerifEye, Catalog Number 8065998300 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, Catalog Number 8065998300 For use during intraocular lens surgery
- Lot codes and dates
- Serial Numbers
366 of 366 codes
C0002C2006C2020C2026C2054C3009RC3010RC3024C3036C3066C3067C3085RC3090C3093C3108C3136C3153C4001C4003C4005C4006C4007C4009C4010C4011C4012C4013C4014C4015C4016C4017C4019C4020C4021C4022C4023C4024C4025C4026C4027C4028C4029C4030C4031C4035C4036C4037C4038C4039C4040C4043C4045C4046RC4047RC4049RC4050RC4052RC4053RC4054RC4055R
- Serial Numbers
- Amount recalled
- 367 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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