Regulatory Open Forum

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  • 1.  medical intervention and adverse event reporting

    Posted 25-Aug-2018 08:45



    Wanted to confirm my understanding of an adverse event when it involves an Intraocular lens (IOL) and needs a replacement.

    Although the damage is not caused to the natural structure (lens)of the human eye , but a an event which  leads to the damage of the IOL such that it needs a replacement(medical or surgical intervention) for correction , will need to be reported , is that correct?


    Thanks & Regards,


    Rashmi Pillay
    Regulatory Affairs Associate


    3-4 Second Avenue

    Mawson Lakes SA, 5095


    T + 61 8 7074 8105


    One Powerful Vision.

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  • 2.  RE: medical intervention and adverse event reporting

    Posted 26-Aug-2018 07:58
    Dear Rashmi,
    If I understand your question correctly this is reportable.


  • 3.  RE: medical intervention and adverse event reporting

    Posted 27-Aug-2018 11:33
    A great place to visit is FDA's TPLC database.  Search your product code (I assume it's HQL).  There is device problem trending and you can drill down to read and download specific MedWatch submissions from your competitors.

    Go here to learn what your competitors believe is an MDR event.  You will most likely get your specific question answered and learn so much more.  You can summarize for your manager and teammates inside and outside of your department.  You will impress people and demonstrate competence in teamwork, communication, product knowledge, business and regulatory strategy, and research skills (to name a few).

    Good luck.

    Also, the rule is essentially this:
    (1) did an adverse event occur?
    (2) or was there medical intervention to avoid an adverse event?
    (3) or could an adverse event occur next time?
    (4) or could there be medical intervention to avoid an adverse event?

    Assumption: your device caused or contributed to the adverse event.

    What do you think?

    Also, have you reviewed the FDA Guidance Medical Device Reporting for Manufacturers, issued on November 8, 2016?

    Rob Yamashita
    Grand Rapids MI
    United States