ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER CENTURION VISION SYSTEM, ACCESSORY, ACTIVE SENTRY HANDPIECE; UNIT, PHACOFRAGMENTATION
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Catalog Number 8065752914 |
Device Problem
Failure to Deliver Energy (1211)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 03/28/2023 |
Event Type
Injury
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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 while performing cataract surgery with an ophthalmic console and phacoemulsification handpiece it had no ultrasound the physician had to perform extracapsular, and the patient left without iol (intraocular lens) implantation, procedure was rescheduled, and vitrectomy was performed with iol implantation.
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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 phacoemulsification (phaco) handpiece (hp) 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 testing on this investigation.A visual assessment of the returned sample revealed no visual nonconformities.The handpiece was connected to a calibrated resistance breakout box, where the input and output impedance were found to be within specification.The returned sample 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.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 indicated that surgery was completed on another day.
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Search Alerts/Recalls
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