ALCON RESEARCH, LLC - HOUSTON CENTURION SURGICAL PROCEDURE PAK; GENERAL SURGERY TRAY (KIT)
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Catalog Number 8065752201 |
Device Problems
Break (1069); Positioning Problem (3009)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/11/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Investigation, including root cause analysis, is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
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Event Description
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A healthcare professional reported that the balanced tip broke in the eye.It was stuck within the sleeve and could be removed from the eye without any problems.The tip was replaced and the procedure was completed without complications.A nurse who attended the procedure reported to a company representative that the tip had to be tightened with a metal tip key shortly before the operation because it was not sitting properly fixed on the handpiece.
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Manufacturer Narrative
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The previous report submitted for this event contained an error, in h.1.¿summary report¿ was inadvertently selected.After a recent systems update, a system error caused the inadvertent additional selection of ¿summary report¿ in h.1.On a select number of reports.The error, which was limited only to the h.1.Field, was promptly identified and quickly rectified.Correction smdrs are being filed for the impacted reports.This smdr is correcting that error for this event.The manufacturer internal reference number is: (b)(4).
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Manufacturer Narrative
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A review of the device history records traceable to the reported lot number, indicates that the product was processed and released according to the product¿s acceptance criteria.Four photos where provided for evaluation.Photo 1 shows a phaco tip wrench, the proximal end (threads) of a phaco tip and an infusion sleeve.Photo 2 shows a label with same product and lot number as reported.Photo 3 shows a console label.Photo 4 shows a phaco tip wrench, the proximal end (threads) of a phaco tip and infusion sleeve with that appears to the distal side of a broken phaco tip inside.The returned phaco tip sample was visually inspected and deemed nonconforming, the phaco tip was broken at the ab hole, jagged, even wall thickness, the remainder of the broken tip was not returned.Wear on threads, flange and nut.The complaint evaluation confirms the phaco tip was broken.The root cause for the broken phaco tip cannot be determined from this evaluation.The phaco tip visual inspection does not show any manufacturing issue that would cause the broken phaco tip.No specific action with regard to this complaint was taken because the root cause for the complaint issue cannot be determined from this evaluation.All phaco tips are 100% visually inspected by trained operators using 30x magnification during the manufacturing process.Any non-conformance, such as the broken phaco tip exhibited on the returned opened sample, is removed from the lot and scrapped.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.No additional action is required at this time.The manufacturer internal reference number is: (b)(4).
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