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FDAJune 30, 2017device

ORA System with VerifEye+ Cart, Catalog Number 8065998307 For use during intraocular lens surgery

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

alcon researchalcon

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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