PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: June 17, 2020 Initiated: April 17, 2020 #Z-2287-2020

Product Description

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.

Reason for Recall

Incorrect IOL diopter

Details

Recalling Firm
Alcon Research LLC
Units Affected
84 units
Distribution
US Nationwide distribution including in the states of TX, PA, CT, IA, MI, NE.
Location
Fort Worth, TX

Frequently Asked Questions

What product 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.. Recalled by Alcon Research LLC. Units affected: 84 units.
Why was this product recalled?
Incorrect IOL diopter
Which agency issued this recall?
This recall was issued by the FDA Devices on June 17, 2020. Severity: Moderate. Recall number: Z-2287-2020.