One collection cassette was received in a card board box.The original packaging was not returned.The part and the lot number cannot be verified or determined.Visual inspection found most of the tubing has been cut off and was not returned.Approximately 8 inches of tubing remains attached to the tubing manifold base.The assembly is dirty with dried solution visible in the lines.Further inspection found two kinks with one being greater than 50%.One kink is in the vitrectomy cutter aspiration line and is bent just in front of the lure connector.The other kink is in the irrigation line and is at the exit of the tubing manifold base.This is the kink that is greater than 50%.Functional testing could not be performed due to the damaged/missing tubing.This assembly does not meet current specifications due to one kink being greater than 50%.The cause of the kinks cannot be determined.Review of manufacturing and sterilization records showed product was manufactured, sterilized and released per requirements.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.No corrective action required.No capa is required, since there is no non-conformance.The investigation is complete.
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