Medical device recalls Moderate risk

Alcon Research LLC recalls Acrysof, IQ IOL w/UltraSert System, AcrySof IQ ASPHERIC IOL, 20.5 D, SP ACRYLIC FOLDABLE LENS, w/UltraSert DELIVERY SYS…

Recall date
April 17, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2287-2020
FDA classification
Class II
Brand / firm
Alcon Research LLC
Sold / distributed
US Nationwide distribution including in the states of TX, PA, CT, IA, MI, NE.

Why it was recalled

Incorrect IOL diopter

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

What was recalled

Acrysof, IQ IOL w/UltraSert System, AcrySof IQ ASPHERIC IOL, 20.5 D, SP ACRYLIC FOLDABLE LENS, w/UltraSert DELIVERY SYSTEM, UV w/BLUE LIGHT FILTER. 13.0mm. LENGTH, 6.0mm ANTERIOR ASYMMETRIC BICONVEX OPTIC, PLANAR HAPTICS.

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