BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTISAN

    MDR report key: 11830548 · Received May 17, 2021

    Report

    Report Number
    8040449-2021-00002
    Event Type
    Injury
    Date Received
    May 17, 2021
    Date of Event
    December 9, 2020
    Report Date
    May 13, 2021
    Manufacturer
    OPHTEC BV
    Product Code
    HQL
    PMA / PMN Number
    P030028
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    A MINIMUM CELL COUNT OF 1500 CELLS/MM2 IS OFTEN AN INDICATION OF PIOL EXPLANTATION BY EXPERTS. THE SURGEON EXPLANTED THE ARTISAN IOL IN THIS CASE AS A PRECAUTION. ADDITIONAL CLINICAL INFORMATION WAS NOT PROVIDED. POTENTIAL CAUSE OF ENDOTHELIAL CELL COUNT (ECC) LOSS THEREFORE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    SHORT DESCRIPTION: A (B)(6) YEAR OLD PATIENT HAS BEEN HOSPITALIZED FOR EXPLANTATION OF AN IMPLANT IN THE ANTERIOR CHAMBER OD (RIGHT EYE), CLIPPED ON THE ANTERIOR SIDE OF THE IRIS. THE PATIENT ALSO UNDERWENT PHACOEMULSIFICATION AND A NEW IMPLANT WAS PLACED IN THE POSTERIOR CHAMBER OF THE RIGHT EYE. BACKGROUND: THE USER REPORTED THE ARTISAN LENS WAS IMPLANTED IN 2002. THE LENS WAS IMPLANTED TO TREAT THE PATIENTS MYOPIA. IT WAS REPORTED THAT THE IMPLANTATION OF THE ARTISAN LENS WAS PERFORMED IN (B)(6). NAME OF THE HOSPITAL AND SURGEON WERE NOT PROVIDED. DETAILED DESCRIPTION: THE USER REPORTED THAT AN ARTISAN LENS (MODEL NOT PROVIDED) WAS EXPLANTED DUE TO ENDOTHELIAL CELL LOSS 19 YEARS AFTER IMPLANTATION. IT WAS REPORTED THAT THE ARTISAN LENS EXPLANTATION WAS PERFORMED AT (B)(6) ON (B)(6) 2020. THE ENDOTHELIAL CELL COUNT (ECC) COUNT OF THE (B)(6) YEAR OLD PATIENT WAS 1800 CELLS/MM2 TWO MONTHS PRIOR TO EXPLANTATION. THE SURGEON EXPLANTED THE LENS AS A PRECAUTION. ARTISAN LENS SPECIFICATIONS: THE USER WAS UNABLE TO REPORT THE SERIAL NUMBER, LOT NUMBER, AND/OR MODEL. NO FURTHER SPECIFICATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727877 ARTISAN ARTISAN MYOPIA HQL OPHTEC BV

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R