Alcon Research, Ltd. recalls Alcon AcrySof IQ IOL with ULTRASERT Delivery System Product Usage: The Alcon AcrySof IQ Intraocular Lens (IOL) is an ac…

Recall date

July 28, 2016

Source

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

Recall number

Z-2708-2016

FDA classification

Class II

Brand / firm

Alcon Research, Ltd.

Sold / distributed

Armenia, Belgium, Bulgaria, Croatia, Finland, France, Germany, Hungary, Italy, Lithuania, Malaysia, Netherlands, Norway, Poland, Portugal, Qatar, Romania, Slovenia, Spain, Sweden, Switzerland, Thailand, United Kingdom (Great Britain and Ireland), and United Arab Emirates. *** While this product is…

Why it was recalled

The ULTRASERT Delivery System from certain lots have an inferior surface characteristic that could result in the IOL becoming lodged in the Delivery System

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Alcon AcrySof IQ IOL with ULTRASERT Delivery System Product Usage: The Alcon AcrySof IQ Intraocular Lens (IOL) is an acrylic foldable singlepiece posterior chamber lens for the replacement of the human crystalline lens in the visual correction of aphakia in adult patients following cataract surgery. This material is capable of being folded prior to insertion. The lens gently unfolds to a fullsize lens body following implantation. The lens has a biconvex optic with supporting haptics The AcrySof IQ IOLs are provided in the ULTRASERT Preloaded Delivery System for a convenient, controlled means to reliably place these lenses into the capsular bag.