Investigation summary: customer returned (90) 1/2cc, 12.7mm, 29g syringes in sealed poly bags with the shelf carton from lot # 6172630.Customer states that silicone from the syringe was injected into the eye of several patients.Thirty out of 90 returned syringes were examined visually and under the microscope and no foreign matter was observed on or in any of the samples.All of these samples were also tested and no material came out of the syringe when fully depressing the plunger rod.As per manufacturing, a review of the device history record was completed for batch# 6172630.All inspections and challenges were performed per the applicable operations qc specifications.There was one (1) notification [(b)(4)] noted that did not pertain to the complaint based on the samples / photo(s) received the investigation concluded: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.Investigation conclusion: bd was not able to duplicate or confirm the customer¿s indicated failure.Root cause description: root cause cannot be determined at this time as the issue is unconfirmed.
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