BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALCON

    MDR report key: 3912362 · Received May 29, 2014

    Report

    Report Number
    3912362
    Event Type
    Malfunction
    Date Received
    May 29, 2014
    Date of Event
    May 8, 2014
    Report Date
    May 29, 2014
    Manufacturer
    ALCON LABORATORIES, INC.
    Product Code
    HQL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    DURING CATARACT SURGERY AFTER IMPLANTING THE LENS THE PHYSICIAN NOTED THAT THE LENS WAS DEFECTIVE (HAD A SCRATCH ON IT). REQUIRED THE PHYSICIAN TO EXPLANT THE LENS AND IMPLANT A NEW LENS. NO INJURY TO PATIENT.======================MANUFACTURER RESPONSE FOR INTRAOCULAR LENS, ALCON (PER SITE REPORTER).======================TRACK AND TREND INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317352 ALCON INTRAOCULAR LENS HQL ALCON LABORATORIES, INC. SN60WF 21.OD NOT FOUND

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR