BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANTABLE COLLAMER LENS (ICL)

    MDR report key: 8678993 · Received June 7, 2019

    Report

    Report Number
    2023826-2019-01027
    Event Type
    Malfunction
    Date Received
    June 7, 2019
    Report Date
    May 13, 2019
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS NOT MARKETED IN THE US. CLAIM# (B)(4).

    Description of Event or Problem · 1

    AN ARTICLE WAS PUBLISHED IN THE JOURNAL OF ADVANCES IN MEDICINE AND MEDICAL RESEARCH IN MARCH 2019 TITLED, 'TORIC AND PHAKIC IOLS FOR THE TREATMENT OF ASTIGMATISM AND/OR HIGH MYOPIA: OUR EXPERIENCE AT PRINCE HASHEM HOSPITAL ZARQA.' THE ARTICLE STATES THAT ONE PATIENT HAD HIGH INTRAOCULAR PRESSURE OF 32 MMHG AFTER ICL IMPLANTATION IN BOTH EYES AND THIS WAS TREATED WITH ANTI-GLAUCOMA DROPS AND ACETAZOLAMIDE 250 MG TABLETS. THE PATIENT WAS FOUND TO BE STEROID RESPONDER AS HER INTRAOCULAR PRESSURE WENT DOWN AFTER SHIFTING TO PRESSURE SPARING STEROID DROPS LOTEMAX. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471812 IMPLANTABLE COLLAMER LENS (ICL) PHAKIC TORIC INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention