ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER CENTURION VISION SYSTEM, ACCESSORY, OZIL TORSIONAL HANDPIECE; UNIT, PHACOFRAGMENTATION
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Catalog Number 8065751761 |
Device Problem
Overheating of Device (1437)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/07/2023 |
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 a sample is available that has not yet been received at manufacturing for evaluation.The manufacturer internal reference number is: (b)(4).
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Event Description
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A nurse reported, that during the cataract surgery an ophthalmic handpiece was hot.The surgery was completed on the same day with another handpiece.There was no patient harm.
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Manufacturer Narrative
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The product under investigation is not a serviceable device.Therefore, a service record review was not performed.However, the phaco handpiece was returned for this investigation for testing.A non-conformance based review of the serial number was performed and did not reveal any potential contributing factors to the reported complaint.A manufacturing device history record (dhr) review was performed prior to product release to ensure that the product was manufactured in compliance with the device master record.Based on the assessment, the product met release criteria.A review for complaints reported against this serial number was performed.No similar complaints were reported for the product serial under investigation.The phaco handpiece was received for this investigation for testing.A visual assessment of the returned sample revealed no obvious non-conformities.When the handpiece was connected to a calibrated breakout test box, the resistance and dissipation between low electrode and high electrode were both within specifications.The returned handpiece was connected to a calibrated system.The handpiece tuned successfully and completed a five minute burn-in test with the system set at 100% ultrasonic and torsional power.During the burn-in test, the temperature of the hp was measured per the product design specification and was found to be within specifications.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 specifications the handpiece was found to meet specifications.Therefore, the root cause of the reported event is inconclusive.Manufacturer 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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Event Description
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Additional information received via follow up indication the handpiece had displayed with error message where it could be completed the tunning process.
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Search Alerts/Recalls
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