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Vitrax

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Vitrax®
Ophthalmology A viscoelastic material used in ophthalmic surgery


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The letter stated that the company's distribution of promotional materials for BioLon and AMO Vitrax sodium hyaluronate viscoelastic devices claiming "enhanced patient outcomes" involve unsubstantiated superiority claims because of a lack of supporting clinical evidence.
Complaint's MDR status probed The third item, involving a complaint about Vitrax illustrates yet another case in which FDA disagreed with a firm's judgment about Medical Device Reporting.
A company probe blamed faulty construction of a sink in an area used for producing Vitrax, an ophthalmic surgical device.
 
 
 
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