ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER CENTURION VISION SYSTEM, ACCESSORY, HANDPIECE; UNIT, PHACOFRAGMENTATION
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Catalog Number ASKU |
Device Problems
Inability to Irrigate (1337); Overheating of Device (1437)
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Patient Problem
Eye Burn (2523)
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Event Date 01/16/2024 |
Event Type
Injury
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Event Description
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A physician reported an incident during surgery where irrigation failure led to a thermal burn experienced by the patient.Upon investigation, it was discovered that the ophthalmic viscosurgical device had accumulated within the irrigation sleeve.Additionally, the surgeon confirmed that the ultrasound tip was pressed against the wound wall to stabilize the eyeball, causing frictional heat generation between the tip and sleeve due to ultrasound transmission.This resulted in insufficient cooling of the tip due to inadequate irrigation fluid flow, leading to the burn.Postoperatively, the thermal burn was treated with steroidal ointments, antibiotics, and nonsteroidal anti-inflammatory drugs.However, the patient discontinued the steroid ophthalmic ointment independently, leading to a worsening of symptoms despite initial improvement.Despite the complication, the surgery was successfully completed on the same day.This report pertains to phacoemulsification handpiece involved in this reported event.
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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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Manufacturer Narrative
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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.The serial is unknown; therefore, a service history review cannot be performed.Based on the information available, the customer reported event cannot be confirmed.The customer reported event cannot be confirmed.Based on the information obtained, the root cause of the reported event is inconclusive.The root cause of the reported event is inconclusive.Therefore, no further actions will be pursued at this time.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.Receipt of complaint sample or additional information pertinent to this complaint will result in re-evaluation of the complaint investigation.The manufacturer internal reference number is: (b)(4).
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