BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTISAN MYOPIA 6/8.5

    MDR report key: 11944799 · Received June 7, 2021

    Report

    Report Number
    8040449-2021-00003
    Event Type
    Injury
    Date Received
    June 7, 2021
    Date of Event
    April 14, 2021
    Report Date
    July 29, 2021
    Manufacturer
    OPHTEC BV
    Product Code
    MTA
    PMA / PMN Number
    P030028
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE RETURNED PRODUCT WAS INVESTIGATED. PRODUCT MEETS SPECIFICATIONS. AS STATED IN THE INITIAL REPORT, REVIEW OF PRODUCT DATA (TRACEABILITY REVIEW) SHOWS THAT PRODUCT WAS MANUFACTURED IN ACCORDANCE WITH SPECIFICATIONS. NO OTHER EVENTS WERE REPORTED REGARDING PRODUCTS FROM THIS LOTS. ADDITIONAL INFORMATION, INCLUDING CLINICAL INFORMATION, WAS REQUESTED IN ORDER TO ANALYZE THE CASE IN DETAIL. NO FURTHER INFORMATION WAS PROVIDED. NO RELEVANT INFORMATION, INCLUDING OTHER PREVIOUS ECC COUNTS, BIOMETRY DATA OF THE EYE, COULD BE PROVIDED. THEREFORE THE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    AN ARTISAN MYOPIA PIOL WAS IMPLANTED ON (B)(6) 2013. DURING A CONSULT ON (B)(6) 2020 IT WAS OBSERVED THAT THE CORNEA WAS DECOMPENSATED IN THE LEFT EYE REQUIRING A CATARACT SURGERY WITH IOL EXPLANTATION COMBINED WITH A CORNEA TRANSPLANTATION. PRIOR TO THE EXPLANTATION, THE ENDOTHELIAL CELL COUNT WAS 1000 CELLS/MM2.

    Additional Manufacturer Narrative · 1

    TRACEABILITY REVIEW SHOWS THAT THE PRODUCT WAS MANUFACTURED IN ACCORDANCE WITH SPECIFICATIONS. NO OTHER EVENTS WERE REPORTED FOR PRODUCTS FROM THIS LOST. NO ADDITIONAL CLINICAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    AN ARTISAN MYOPIA PIOL WAS IMPLANTED ON (B)(6) 2013. DURING A CONSULT ON (B)(6) 2020, IT WAS OBSERVED THAT THE CORNEA WAS DECOMPENSATED IN THE LEFT EYE REQUIRING A CATARACT SURGERY WITH IOL EXPLANTATION, COMBINED WITH A CORNEA TRANSPLANTATION. PRIOR TO THE EXPLANTATION, THE ENDOTHELIAL CELL COUNT WAS 1000 CELLS/MM2. A CORNEAL TRANSPLANT WAS PERFORMED (DSAEK). THE LENS WAS REPLACED WITH A REGULAR CATARACT IOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    846222 ARTISAN MYOPIA 6/8.5 ARTISAN MYOPIA MTA OPHTEC BV 204001W 111072

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention