Alcon 8065751900

Additional information and product sample have been requested. Investigation, including root cause analysis, is in progress.

A supplemental mdr will be filed as necessary in accordance with 21 cfr A device history record dhr review was conducted. According to the dhr review, one lot was reprocessed for an anomaly septum damage that could have contributed to the customer complaint. The device history record review does not point to a root cause because the lot was reprocessed and the product released met the manufacturer's acceptance criteria.

Two lots were reprocessed for anomalies damaged tip and missing cap that did not contribute to the customer complaint. Four lots had no anomaly found based on the dhr review. No additional investigations are required based on device history reviews. A complaint history examination indicates this is the ninth complaint against the components of the reported final lot.

No sample has been returned for evaluation; therefore, the condition of the product could not be verified. An exact root cause could not be determined as to why the trocar cannula exhibited the leaking condition described. An internal investigation has been opened to address this issue. The manufacturer internal reference number is: b 4. Shenzhen Chongming Electronic Technology Co. Contact Details Assessed Supplier.

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