BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALCON ACRYSOF IOL IMPLANT

    MDR report key: 320932 · Received March 14, 2001

    Report

    Report Number
    MW1021334
    Event Type
    Malfunction
    Date Received
    March 14, 2001
    Date of Event
    February 26, 2001
    Report Date
    March 14, 2001
    Manufacturer
    ALCON LABORATORIES, INC.
    Product Code
    HQL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    NOTIFICATION OF MEDICAL DEVICE RECALL FROM ALCON LABORATORIES APPROXIMATELY 3/8/01. THIS SPECIFIC POSTERIOR LENS IMPLANT ON RECALL HAD ALREADY BEEN IMPLANTED. PHYSICIAN NOTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11274 ALCON ACRYSOF IOL IMPLANT POSTERIOR INTRAOCULAR LENS IMPLANT HQL ALCON LABORATORIES, INC. MA60BM *

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Other