ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER CENTURION VISION SYSTEM, ACCESSORY, ACTIVE SENTRY 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
Intraocular Pressure Increased (1937); Capsular Bag Tear (2639); Eye Pain (4467)
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Event Date 01/01/2024 |
Event Type
Injury
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Event Description
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A government agency reported a case involving cataract surgery conducted using a phacoemulsification handpiece.The patient encountered a capsular rupture before implantation, leading to an extended operation time.The surgeon observed hyperalgesia associated with an elevation in intraocular pressure.Additionally, there was a change in the implant plan, with placement in the sulcus, and the incision size increased to 3.2 mm due to a non-preloaded implant.Subsequently, the physician noted prolonged healing, uncertain refractive outcomes however additional complications have been reported in late post-operative period.Surgeon also stated in complicated divide step on soft nuclei, excessive ultrasonic power from the handpiece resulted in inaccurate destruction of the nucleus.In the quarters step, strong anterior chamber instability occurred, accompanied by ineffective aspiration from the handpiece.Coupling aspiration with ultrasound suddenly led to uncontrollable aspiration of the bag or capsule.Additional information has been requested none received till date.This report pertains two of five patients for the reported events.
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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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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 lot/batch/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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Search Alerts/Recalls
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