ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER CENTURION VISION SYSTEM, ACCESSORY, ACTIVE SENTRY HANDPIECE; UNIT, PHACOFRAGMENTATION
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Catalog Number 8065752914 |
Device Problems
Noise, Audible (3273); Suction Failure (4039)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/29/2024 |
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 that the ophthalmic handpiece was unable to aspirate during the ultrasound, accompanied by a ringing sound suggestive of a blockage.The surgery was successfully completed after substituting the handpiece with another one intended for ivs.Unfortunately, the specific procedure type, the involved eye, and the patient identifier are unavailable.Importantly, no patient harm occurred.
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Search Alerts/Recalls
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