Alcon Research, Ltd. recalls ReSTOR intraocular lens and ReSTOR Toric intraocular lens. The Alcon AcrySof IQ ReSTOR and IQ ReSTOR Toric intraocula

Recalled August 19, 2015 · FDA recall Z-2323-2015 · Alcon Research

Hazard

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

Units

45,391

Sold at

Distribution Japan, No US distribution.

Description

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

Product

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.

Manufacturer(s)

Alcon Research, Ltd.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →