It was reported that there was an issue with jp016 - primeline 3/4 lid anthracite.According to the complaint description, the lid cracked.One lid cracked in the middle, and another lid popped off the container during sterilization.There was a significant surgery delay of 40 minutes.Staff had been setting up and preparing for a vitrectomy procedure.There was no patient involvement.The malfunction is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2021-00644 (400528226 - jp016).9610612-2021-00645 (400528225 - jp016).
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Investigation results: as of the date of this report the complaint product was not provided for investigation.Therefore, a thorough investigation is not possible.Batch history review: due to the fact that no lot number was provided, a review of the device history records for the complained device is not possible.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.In the event that the complaint product will be provided for investigation in the future, an update of this report will be provided unsolicited.Based upon the investigations results a capa is not necessary.
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