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); Power Problem (3010)
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Patient Problems
Rupture (2208); Intraocular Pressure Decreased (4468)
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Event Date 08/01/2023 |
Event Type
Injury
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Event Description
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A government agency reported that during a cataract surgery patient experienced capsular rupture prior to implantation.There was instability of the structure, so no implantation was carried out, and a repeat surgery was required within a month to place an iris-fixed implant.The patient was still healing, with partial removal of the stitches, iterative appointments, and post-operative astigmatism.Surgeon also stated in complicated divide step on soft nuclei too much ultrasonic power from an ophthalmic handpiece led to inaccurate destruction of the nucleus.In quarters step strong anterior chamber instability was experienced.An ophthalmic handpiece had ineffective aspiration.Upon coupling aspiration with ultrasound abruptly with uncontrollable aspiration of the bag or capsule.
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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.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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