BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOLTENO3

    MDR report key: 19915633 · Received August 6, 2024

    Report

    Report Number
    3001227772-2024-00001
    Event Type
    Injury
    Date Received
    August 6, 2024
    Date of Event
    April 16, 2023
    Report Date
    August 6, 2024
    Manufacturer
    MOLTENO OPHTHALMIC LTD.
    Product Code
    KYF
    UDI-DI
    09419196000212
    PMA / PMN Number
    K062252
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADVERSE EVENT WITHOUT IDENTIFIED DEVICE OR USE PROBLEM. KNOWN INHERENT RISK OF DEVICE. FDA REPORT DELAYED DUE TO INITIAL INCORRECT ASSESSMENT OF THIS EVENT AS NOT REPORTABLE. (B)(4) . (IMPORTER) AND MOLTENO OPHTHALMIC LTD, (MANUFACTURER) ARE SUBSIDIARIES OF NOVA EYE MEDICAL LTD.

    Description of Event or Problem · 0

    ON 29 AUG 2023, MOLTENO OPHTHALMIC LTD BECAME AWARE OF A REPORTED ADVERSE EVENT FOR THE MOLTENO3 GLAUCOMA DRAINAGE DEVICE, (B)(6). DATE OF IMPLANT WAS (B)(6) 2023. PATIENT DETAILS OBTAINED INDICATE A POST SUPRACHOROIDAL HEMORRHAGE OCCURRED ON (B)(6) 2023 IN THE PATIENT'S RIGHT EYE DUE TO THE OPENING OF THE GLAUCOMA TUBE AND LIGATION SUTURE. CONSEQUENCE FOR THE PATIENT WAS LOSS OF VISION. THE OUTCOME ANTICIPATED BY THE SURGEON WAS LONG-TERM POOR VISION. THE INITIAL REPORT RECEIVED INDICATED THAT TWO PATIENTS HAD EXPERIENCED HYPOTONY AND LOSS OF VISION AS A RESULT OF A MOLTENO GDD IMPLANT. HOWEVER, DURING FOLLOW UP WITH THE SURGEON, ONLY ONE PATIENT DETAILS WERE PROVIDED. NO INDICATION OF HYPOTONY WAS INCLUDED IN THESE DETAILS. THE PATIENTS PRE-OP PRESSURE WAS 30MMHG IN RIGHT EYE. POST-OP PRESSURE RANGED FROM 38 TO 47MMHG ON MAXIMUM TOPICAL MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1561845 MOLTENO3 GLAUCOMA DRAINAGE DEVICE KYF MOLTENO OPHTHALMIC LTD. SS 364 09419196000212

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Other