This product malfunction was originally reported under an alternative summary report (e2000003).The sample has been returned and investigation was updated, which prompts evaluation and conclusion coding to be updated.As the alternative summary report e2000003 has been revoked, the updated information (product investigation and coding) is being sent via this 3500a report.The product was returned for analysis and the reported damage was observed.Additional observations were as follows: the iol was returned positioned correctly in the iol case.Solution is dried on the iol.The optic s scratched/marked rejectable.We are unable to determine the root cause for the reported complaint "lens desterilized, defective".The returned iol shows evidence of possible handling by the customer due to the presence of solution dried on the iol.In addition to this, all iols are 100% cosmetically inspected as per approved manufacturing procedures and the observed optic 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.All product and batch history records are quality reviewed prior to product release.The manufacturer internal reference number is: (b)(4).
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