The product was returned for analysis and the reported complaint was not observed.Intraocular lens (iol) returned in pieces in a zip lock bag.Solution is dried on both surfaces of the optic.Both haptics are broken/torn and not returned.The optic is torn/split-cut dividing the iol in two(2) and scratched/marked rejectable.The iol colour appears natural, which is consistent with model company lens.The product investigation could not identify a root cause as the reported complaint was not observed.The iol colour appears natural, which is consistent with model company lens.The product was subject to handling and the reported damage was highlighted post implantation.The returned iol shows evidence of handling by the customer due to the presence of solution dried on both surfaces of the returned segments.In addition to this, all iols are 100% cosmetically inspected as per approved manufacturing procedures and the observed damage would not meet our current release criteria.Based on these investigation findings, we are unable to verify if the iol contributed to the event.Based on the results from the product history record, the products met release criteria.There have been no other complaints for this lot.The manufacturer internal reference number is: (b)(4).
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