ALCON RESEARCH, LLC - HOUSTON CONSTELLATION VISION SYSTEM, ACCESSORY, IRRIGATION/ASPIRATION TUBING SET; UNIT, PHACOFRAGMENTATION
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Catalog Number 8065750918 |
Device Problems
Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/26/2022 |
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 physician reported the tube connecting the handpiece was not tight, resulting in water leakage during a cataract surgery.The product was replaced and the surgery was completed.There was no patient harm.
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Manufacturer Narrative
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A review of the device history record traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.Current tracking indicates no adverse trend for this lot for this event.The returned irrigation/aspiration (i/a) manifold in a soft tray was visually inspected and no obvious defects were found.The sample was tested with the lab stock cassette and the other components using a calibrated console representing the current software version.The sample could tune with the ultrasonic handpiece, the 0.9mm air bypass tip (abs) tip and infusion sleeve.No leakage or detachment occurred during tuning with the handpiece.Fluid could irrigate and aspirate through the handpiece in the console i/a mold.The connectors and fittings on the i/a manifold were tightened firmly and securely on the cassette and handpiece.The root cause of the customer's complaint could not be established; the returned sample functioned per specifications.After an investigation of this complaint, it has been determined that this sample functioned per specifications; therefore, no corrective action is required at this time.Current tracking indicates no adverse trend for this lot for this event as the product met specifications.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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