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

Recall date

April 15, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2323-2015

FDA classification

Class I

Brand / firm

Alcon Research, Ltd.

Sold / distributed

Distribution Japan, No US distribution.

Why it was recalled

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

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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.