BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFTEC HDO

    MDR report key: 10392067 · Received August 11, 2020

    Report

    Report Number
    9613160-2020-00017
    Event Type
    Injury
    Date Received
    August 11, 2020
    Date of Event
    April 16, 2014
    Report Date
    May 13, 2020
    Manufacturer
    LENSTEC BARBADOS, INC.
    Product Code
    HQL
    PMA / PMN Number
    P090022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON THE (B)(6) 2014, LENSTEC (BARBADOS) INC RECEIVED VIA EMAIL, A NOTIFICATION THAT LENSES WERE BEING RETURNED VIA THE RETURNS AUTHORIZATION NUMBER 1184. THE LENSES IN QUESTION CARRIED THE NOTATION "CARTRIDGE DEFECTIVE". NO FURTHER INFORMATION REGARDING THE LOT NUMBER FOR THE CARTRIDGE, IF THERE WAS ANY PATIENT INJURY, OR IF ANOTHER LENS WAS SUCCESSFULLY IMPLANTED WAS PROVIDED. THE LENSES WERE RECEIVED AT LENSTEC (BARBADOS) INC ON THE (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    855891 SOFTEC HDO INTRAOCULAR LENS HQL LENSTEC BARBADOS, INC. 133827

    Patients

    Seq Age Sex Outcome Treatment
    1