A physician reported that after a pars plana vitrectomy (ppv) surgery, nine patients experienced vision loss and visual scotoma and developed blind spot in the infero temporal with damage to the retinal ganglion cell layer supero-nasal.The patients did not receive expansile gas.The air flow from the infusion cannula during the air-gas exchange, angled directly towards the superior nasal paracentral retina may have contributed to the patient's visual scotoma.
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The lot complaint history and dhr were not reviewed as no lot information was available for this complaint.The sample was not received at the investigating site for this complaint report; visual inspection or functional testing could not be conducted.If a sample is returned at a later date, the investigation will be reopened and the sample will be evaluated.The root cause of the customer's complaint could not be established as a sample has not been received.Without analysis of the sample, it is not possible to isolate the root cause.As the root cause is unknown, the relationship, if any, of the device to the reported incident cannot be determined.All lots are verified that all required tests have been performed and all acceptance criteria are met prior to release.After an investigation of this complaint, it has been determined that no action will be taken at this time as a sample was not returned and no root cause could be established.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.The manufacturer internal reference number is:(b)(4).
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