BEUDAMED
    FDA Enforcement 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.

    Recall: Z-2287-2020 · Reported June 17, 2020

    Enforcement

    Recall Number
    Z-2287-2020
    Event ID
    85563
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Alcon Research LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    June 17, 2020
    Initiation Date
    April 17, 2020
    Classification Date
    June 5, 2020
    Termination Date
    February 5, 2021
    Address
    Aspex Facility, 6201 South Fwy, Fort Worth, TX, 76134-2099, United States

    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

    Incorrect IOL diopter

    Code Info

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

    Distribution

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

    Quantity

    84 units