Weight and ethnicity: not applicable, as there was no patient contact with the device.Implant date: if implanted, give date: not applicable, no patient contact with the device.Explant date: if explanted, give date: not applicable, no patient contact with the device.Device evaluation: the device was not returned at the manufacturing site; therefore, product testing could not be performed, and the customer¿s reported complaint could not be verified.Manufacturing record review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.A search of complaints related to this production order (po) was performed.The search revealed one additional complaint folder was received for this po.Although the complaint issues reported are related, the issue could not be confirmed as related to manufacturing.Therefore, no escalations are required.Conclusion: as a result of the investigation there is no indication of a product quality deficiency, and the reported issue could not be confirmed.Attempts have been made to obtain missing information; however, to date, the information has not been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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Corrected data: upon further review, it was noted that the code "4114" was inadvertently entered in the section "h6" of the initial mdr report instead of "4115" and it was also noted that section "h10 - device evaluation" in the initial mdr report inadvertently did not indicate that the device was discarded, which the information has been corrected in this supplemental mdr report.The following fields were updated accordingly: section h6: type of investigation: 4115.Device evaluation: the device was not returned for evaluation as it was discarded; therefore, product testing could not be performed, and the customer¿s reported complaint could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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