Z-2287-2020 Class II Terminated

Recalled by Alcon Research LLC — Fort Worth, TX

Recall Details

Product Type
Devices
Report Date
June 17, 2020
Initiation Date
April 17, 2020
Termination Date
February 5, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
84 units

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

Distribution Pattern

US Nationwide distribution including in the states of TX, PA, CT, IA, MI, NE.

Code Information

Lot number 12726594; Model Number: AU00T0V205; UDI # 038065GMN000065H7; 0380652394772(17)220630(21)12726594000(30)1