FDAClass IAugust 19, 2015

ReSTOR intraocular lens and ReSTOR Toric intraocular recall

ReSTOR intraocular lens and ReSTOR Toric intraocular lens. The Alcon AcrySof IQ ReSTOR and IQ ReSTOR Toric intraocular lenses are posterior chamber…

Why was ReSTOR intraocular lens and ReSTOR Toric intraocular recalled?

There are reports of post - operative inflammation and/or toxic anterior segment syndrome (TASS) after cataract surgery.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Model Numbers: SN6AD1, SN6AD3, SV25T0, MN6AD1,SND1T3, SND1T4, SND1T5 and SND1T6 and all lot numbers.

Product
ReSTOR intraocular lens and ReSTOR Toric intraocular lens. The Alcon AcrySof IQ ReSTOR and IQ ReSTOR Toric intraocular lenses are posterior chamber…
Recalling firm
Alcon Research, Ltd.
Quantity
45,391
Distribution
Distribution Japan, No US distribution.
Recall date
August 19, 2015
Classification
Class I
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls