Six images were submitted and reviewed.Slit lamp images were with various apertures illuminating the iols through dilated pupils.The right eye images show what appear to be a more diffuse confluence where it is difficult to discern individual refractile bodies and a yellow appearance as reported.Associated products were not provided.It is unknown if qualified products were used.Only photos were available to view.It is difficult to make a final determination without evaluation of the physical sample.Information was provided in the file the lens was implanted in 2008.A director reviewed the provided photos.The following review was provided: the right eye images show what appear to be a more diffuse confluence where it is difficult to discern individual refractile bodies and a yellow appearance as reported.When refractile bodies such as microvacuoles occur within iols, numerous small reflections of light can occur.Depending upon the light spectrum, intensity and beam size of the slit lamp, the angle of incidence of that light, and the size and density of the microvacuoles and their distribution, the light passing back to the observer can appear slightly different in color.Numerous clinical factors can affect visual performance and the impact of microvacuoles on vision lacks consensus based on numerous studies.The manufacturer internal reference number is: (b)(4).
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