ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER CENTURION VISION SYSTEM, ACCESSORY, HANDPIECE; UNIT, PHACOFRAGMENTATION
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Catalog Number 8065752914 |
Device Problems
Energy Output Problem (1431); Suction Problem (2170)
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Patient Problems
Cusp Tear (2656); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 11/18/2023 |
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 nurse reported that during a cataract surgery an ophthalmic operating console failed to perform the fill test system was restarted and the test was performed.However, during the surgery, the system experienced a vacuum delivery failure, resulting in insufficient aspiration.The surgeon attempted various measures such as changing the handpiece, tip, and cassette, but the issue persisted, leading to the system being turned off multiple times.Despite reconnecting the cassette and altering the handpiece, the vacuum problem persisted, causing an increase in ultrasound impulse that led to the rupture of the zonules and displacement of the crystalline towards the vitreous in the patient's eye.To mitigate the situation, the surgery proceeded using an alternative ophthalmic system, necessitating a posterior vitrectomy, posterior planectomy, and sulcus lens implant to complete the procedure additional information has been requested none received till date.This report pertains to phacoemulsification handpiece involved in this reported event.
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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.Based on the information obtained, the root cause of the reported event is inconclusive.Specific product identifiers (serial number) were not provided and could not be determined at this time.However, all device history records are reviewed prior to product release to ensure the product was manufactured in compliance with the device master record and meets release criteria.A review for complaints reported against this serial number cannot be performed as the serial number is unknown.Based on the information obtained, 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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Manufacturer Narrative
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The manufacturer internal reference number is: (b)(4).
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Manufacturer Narrative
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Corrected information is provided in section d.4 and ,h.3,h.4 the manufacturer internal reference number is: (b)(4).
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