ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER CENTURION VISION SYSTEM, ACCESSORY, ACTIVE SENTRY HANDPIECE; UNIT, PHACOFRAGMENTATION
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Catalog Number 8065752914 |
Device Problem
Vibration (1674)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/14/2020 |
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.(b)(4).
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Event Description
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A physician reported that during a surgical procedure the phacoemulsification (phaco) suddenly fails from the phaco handpiece.There is still suction but no vibrations.This is one of multiple reports from this facility.Additional information has been requested and received which indicated the event occurred during the phaco phase of a cataract extraction procedure.There was no system message displayed.The case was completed with no harm to the patient.
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Manufacturer Narrative
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The phacoemulsification (phaco) handpiece was received for evaluation.A visual assessment of the returned sample found no visual non-conformities.The handpiece was connected to a resistance test box, where its¿ input and output impedance were found to be within specification.The handpiece tuned successfully and completed a five-minute burn-in test with the system set at 100% ultrasonic and torsional power.The handpiece was connected to dynamic tuning fixture (dtf) for stroke length testing on the longitudinal and torsional movements, which found the handpiece to meet manufacturer specifications per manufacturing test procedure (mtp).The returned handpiece was found to meet specifications.Therefore, the root cause of the reported event cannot be determined conclusively.The manufacturer internal reference number is: (b)(4).
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