Cosmetic Extraocular Implants. But Why??

January 4th, 2007 Tim Odell Ophthalmology

You’ve been warned: the following movie is of an eye surgery. The weak of stomach should not click play. Apparently, this is an instructional video for implanting a little metal charm under some of the outer membranes of the eye. Now that cosmetic contact lenses are out of the picture, apparently we’ve migrated to this?

The charm kind of looks like a heart; but if that’s the case, it went in upside down.
This is from the Netherlands Institute for Innovative Ocular Surgery, whose site looks a lot more legitimate than the concept of cosmetic extra ocular implants.

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18octallday19alldayWorld Congress on Polycystic Ovarian Syndrome and Fertility, 2018Abu Dhabi, UAE

18octallday19alldayManaging Your Complaints and Obstacles in Post-Market Requirements -- Results from Top Medical Device Observations During an InspectionMinneapolis, MN, USA

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Post-Market activities, Complaint Handling, MDRs, and Recalls are expensive, time consuming, and often lead to more serious financial consequences. Over 80% of FDA Inspection target observations for lack of compliance in these areas.

By attending this seminar, you will discover:

How to overcome one of the biggest obstacles device manufacturers face
How the FDA expects you to develop and implement proper handling of complaints reportable or non-reportable, product complaint handling and documentation
How and when to file Medical Device Reports (MDR), effective and appropriate communication with the appropriate regulatory agencies in the event of a recall.
How to conduct a correction and removal actions to avoid a recall crisis, including required recordkeeping, expectation from FDA and other regulatory agencies in the event of a recall and key factors in implementing and maintaining compliance with the regulations and real life experiences of FDA.

**New course materials have been added, updated content will include:

Creating Standard Operating Systems (SOPs) for Post-Market Quality Systems and
What to expect from the changes in ORA with Inspection Structure Realignment

This Seminar will have you stop spinning your wheels with nonessential activities, and leave you with a comprehensive learning package that only Rita Hoffman, a former FDA CDRH Recall Branch Chief with experience across the device, drug and veterinary industries can provide.

Spend one and a half days in an interactive course led by Ms. Rita Hoffman, Former FDA CDRH Recall Branch Chief with over 36 years with FDA and leading Industry Expert, who will provide the participants with tools to minimize risk of regulatory enforcement actions.

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october 18 (Thursday) - 19 (Friday)

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Compliance Online 80068SEM

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18octallday19allday18th Global Ophthalmology, Optometry and Glaucoma Conference, 2018Helsinki, Finland

18octallday19alldayBiology and Pathology of Infectious Disease Conference, 2018Helsinki, Finland

18octallday19allday14th Global Biomarkers Summit, 2018Amsterdam, Netherlands

22octallday23alldayInternational Conference on Breast Cancer, 2013Vancouver, British Columbia, Canada