Reported Aug 19, 2015 · Terminated
ReSTOR intraocular lens and ReSTOR Toric intraocular lens. The Alcon AcrySof IQ ReSTOR and IQ ReSTOR Toric intraocular…
Alcon Research, Ltd.
High riskUsing this product could cause serious injury, illness or death — stop using it now.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?
- ReSTOR intraocular lens and ReSTOR Toric intraocular lens. The Alcon AcrySof IQ ReSTOR and IQ ReSTOR Toric intraocular lenses are posterior chamber lenses intended as optical implants designed to replace the human crystalline lens in adult patients following cataract surgery. The lenses subject to this correction are manufactured specifically for Japan.
- Lot codes and dates
- Model Numbers
SN6AD1SN6AD3SV25T0MN6AD1SND1T3SND1T4SND1T5 and SND1T6 and all lot numbers
- Model Numbers
- Amount recalled
- 45,391
Why it was recalled
Stop using this product now
There are reports of post - operative inflammation and/or toxic anterior segment syndrome (TASS) after cataract surgery.
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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