Evaluation summary: the product was not returned.Product history records were reviewed and the documentation indicated the product met release criteria.A company representative reviewed the provided photos.Images show pseudophakic eyes (unable to identify the implanted iol models from the pictures).The image is focused mainly on the iol body, multiple light scattering artifacts (spots) can be observed, these spots are of variable diameter, the diameter cannot be determined accurately.In addition it is observed a whitening of the capsulorhexis remnant.The product investigation could not identify a root cause for the reported issue.Although a definitive conclusion cannot be determined based solely on static pictures, the observations may be compatible with glistenings and/or inflammatory cells deposits on iol surfaces, and anterior capsule opacification.There have been no other complaints reported in the lot number.Additional information has been requested.(b)(4).
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