ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER CENTURION VISION SYSTEM; UNIT, PHACOFRAGMENTATION
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Catalog Number 8065751763 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hypopyon (1913); Inflammation (1932); Uveitis (2122); Toxic Anterior Segment Syndrome (TASS) (4469)
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Event Date 02/18/2022 |
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 a patient experienced toxic anterior segment syndrome (tass) following a cataract extraction procedure.Upon examination of the patient, the surgeon noted 3+ aqueous cell, hypopyon, 1+ conjunctival and 1+vitreous inflammation.The patient was prescribed with post-operative steroid, antibiotic, steroid (tobramycin/dexamethasone) and non-steroidal anti-inflammatory (lidocaine) drugs for the events.No cultures were performed.The patient's symptoms have been continuing with topical medication.This is the third of three reports for this events.
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Manufacturer Narrative
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Specific product identifiers (lot number, batch number, and/or 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 lot/batch/serial number is unknown.The lot/batch/serial is unknown; therefore, a service history review cannot be performed.The root cause cannot be determined conclusively.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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