FDA-Device2015-08-19Class I
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.
Alcon Research, Ltd.
Hazard
There are reports of post - operative inflammation and/or toxic anterior segment syndrome (TASS) after cataract surgery.
Sold states
Distribution Japan, No US distribution.
Affected count
45,391
Manufactured in
6201 South Fwy, N/A, Fort Worth, TX, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2323-2015Don't want to check this manually?
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