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Catalog Number ASKU |
Device Problem
No Apparent Adverse Event (3189)
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Patient Problems
Hypopyon (1913); Inflammation (1932); Uveitis (2122); Toxic Anterior Segment Syndrome (TASS) (4469); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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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 aqueous cell, aqueous fibrin, hypopyon, conjunctival inflammation.The patient was prescribed with post-operative antibiotic, steroid and non-steroidal anti-inflammatory drugs.No cultures were performed.The patient's symptoms have been resolving with topical medication.This is the first of three reports for this event.
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Manufacturer Narrative
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There was no further information made available.With no additional, related information provided, the customers¿ reported event was not able to be confirmed.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.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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Code 3331 has been replaced by 4119.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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